Want to become 510K compliant with teh FDA?

Doris A

Doris A

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Same as abutments. Mill it with a machine, you need FDA. Do it by hand, not required.
That's what I thought, just wanted to be sure.
 
BobCDT

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Whose arguing? I'm just questioning whether a Dentist has to have an FDA compliant means to make custom abutments.
Sorry if I misinterpreted your post. To the best of my knowledge, DDS's do not need to be FDA compliant. If you find out otherwise it would be good to know.
 
Affinity

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Just another scare tactic money grab from the feds. Has anyone gotten a letter from them that hasnt willingly given them their address?
 
BobCDT

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I believe they are going into labs that are marketing CA's manufactured in-house on websites. Honestly, I'm feeling like the FDA will be regulating labs more and more over the next decade. We are only at the beginning.
 
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Tim Torbenson

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Whose arguing? I'm just questioning whether a Dentist has to have an FDA compliant means to make custom abutments.

A dentist with an in house lab is not viewed by the FDA as a commercial dental laboratory as long as the dentist is only doing lab work for his/her patients and not servicing other dentists outside of their practice. It is the commercial laboratory that is manufacturing for a number of dentists/clients that will fall under the FDA over site.
 
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Whats the difference? I know every question about beauracracy is rhetorical, but in an in-house lab situation the Dr isnt "making" the crown/abutment, the tech is. Even still there is no oversite of Drs! Totally useless! The DIY 'workaround' Drs are the only ones benefitting here. And why? Does dental school automatically get you FDA 510k clearance? Just tighten the noose a bit more on our lab industry.
 
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Tim Torbenson

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Bob, does this include the State requirements for FDA compliance, such as the California State Food and Drug Branch. I have found the CA FDB requires a lot more work than the FDA.
Whats the difference? I know every question about beauracracy is rhetorical, but in an in-house lab situation the Dr isnt "making" the crown/abutment, the tech is. Even still there is no oversite of Drs! Totally useless! The DIY 'workaround' Drs are the only ones benefitting here. And why? Does dental school automatically get you FDA 510k clearance? Just tighten the noose a bit more on our lab industry.

The question is not who is making the restoration, the question is are they selling the restoration outside of their business? An in house dental lab is not a commercial lab and as such, in today's regulatory environment, is exempt. This may change in the future as the FDA continues to provide more oversight in the dental laboratory segment. The same would be true for the dental technology schools.

This is not a 510(k) clearance issue, it is compliance with Title 21 CFR 820 of the FDA GMP guidance. Below is a portion of a newsletter on the topic:
Why is the FDA Looking at dental laboratories?
In the past, most dental laboratories have been able to avoid significant FDA scrutiny due to the hand-crafted nature of each case. For years dental technicians have used hand instruments to create wax patterns, brushes to stack porcelain and hand pieces to grind in contours and anatomy without any real ability to regulate, control or accurately document the process.

Without the ability of the laboratory industry to establish and follow structured processes in heavily-custom manual operations, the FDA’s main regulatory focus has been the materials used in the dental laboratory.

As our industry moved to CAD/CAM (Computer-Aided Design / Computer Aided Manufacturing) processes such as milling and 3D printing, dental laboratory production has moved from manual operations to more true automated and controlled manufacturing operations. When manufacturing operations are used to produce medical devices and those devices are marketed for sale, the FDA has an obligation to make sure device manufacturers are following appropriate protocols in the design and manufacture of their devices. Those protocols are also known as Medical Device Good Manufacturing Practices. (FDA 21 CFR 820 https://www.fda.gov/) Any manufacture of medical devices must be compliant with the Title 21 CFR 820 regulation.
 
JMN

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The question is not who is making the restoration, the question is are they selling the restoration outside of their business? An in house dental lab is not a commercial lab and as such, in today's regulatory environment, is exempt. This may change in the future as the FDA continues to provide more oversight in the dental laboratory segment. The same would be true for the dental technology schools.

This is not a 510(k) clearance issue, it is compliance with Title 21 CFR 820 of the FDA GMP guidance. Below is a portion of a newsletter on the topic:
Why is the FDA Looking at dental laboratories?
In the past, most dental laboratories have been able to avoid significant FDA scrutiny due to the hand-crafted nature of each case. For years dental technicians have used hand instruments to create wax patterns, brushes to stack porcelain and hand pieces to grind in contours and anatomy without any real ability to regulate, control or accurately document the process.

Without the ability of the laboratory industry to establish and follow structured processes in heavily-custom manual operations, the FDA’s main regulatory focus has been the materials used in the dental laboratory.

As our industry moved to CAD/CAM (Computer-Aided Design / Computer Aided Manufacturing) processes such as milling and 3D printing, dental laboratory production has moved from manual operations to more true automated and controlled manufacturing operations. When manufacturing operations are used to produce medical devices and those devices are marketed for sale, the FDA has an obligation to make sure device manufacturers are following appropriate protocols in the design and manufacture of their devices. Those protocols are also known as Medical Device Good Manufacturing Practices. (FDA 21 CFR 820 https://www.fda.gov/) Any manufacture of medical devices must be compliant with the Title 21 CFR 820 regulation.
Copy/print

Thanks!
 
JMN

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Whats the difference? I know every question about beauracracy is rhetorical, but in an in-house lab situation the Dr isnt "making" the crown/abutment, the tech is. Even still there is no oversite of Drs! Totally useless! The DIY 'workaround' Drs are the only ones benefitting here. And why? Does dental school automatically get you FDA 510k clearance? Just tighten the noose a bit more on our lab industry.
It's the same pass that Dentists get on gas passing. Anesthesiologists study for 8 years to do it, but a few semester hours is all they do. Yeah, the options are more limited, but not as much as you'd like. I can't recall how many ads I've seen/heard for sedation dentistry. Knowing how closely many adhere to material prep guidelines, it's amazing that there are not far more issues than we hear of from maladministration.
 
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Why is the FDA Looking at dental laboratories?
In the past, most dental laboratories have been able to avoid significant FDA scrutiny due to the hand-crafted nature of each case. For years dental technicians have used hand instruments to create wax patterns, brushes to stack porcelain and hand pieces to grind in contours and anatomy without any real ability to regulate, control or accurately document the process.

Without the ability of the laboratory industry to establish and follow structured processes in heavily-custom manual operations, the FDA’s main regulatory focus has been the materials used in the dental laboratory.

As our industry moved to CAD/CAM (Computer-Aided Design / Computer Aided Manufacturing) processes such as milling and 3D printing, dental laboratory production has moved from manual operations to more true automated and controlled manufacturing operations. When manufacturing operations are used to produce medical devices and those devices are marketed for sale, the FDA has an obligation to make sure device manufacturers are following appropriate protocols in the design and manufacture of their devices. Those protocols are also known as Medical Device Good Manufacturing Practices. (FDA 21 CFR 820 https://www.fda.gov/) Any manufacture of medical devices must be compliant with the Title 21 CFR 820 regulation.

This is one of the most absurd things Ive heard in my career. If anything CAD/CAM makes it more precise than handwork, but that aside, it DOES NOT protect the patient, only because a lab is deemed 'commercial', like a dentist isnt in it for money. While I agree that any old mill off the shelf shouldnt be allowed to mill the interface of an abutment, if a dentist can do it himself and put it in a patients mouth, then he can (or should be able) approve a lab making one for him on another premises. Again, theres no oversight on the dentist! EVER!
Its not like what I, or anyone, says matters anymore, the giant ball has started rolling. Maybe I should look into becoming an FDA inspector. BangheadBirdDeal
 
vurban210

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This is one of the most absurd things Ive heard in my career. If anything CAD/CAM makes it more precise than handwork, but that aside, it DOES NOT protect the patient, only because a lab is deemed 'commercial', like a dentist isnt in it for money. While I agree that any old mill off the shelf shouldnt be allowed to mill the interface of an abutment, if a dentist can do it himself and put it in a patients mouth, then he can (or should be able) approve a lab making one for him on another premises. Again, theres no oversight on the dentist! EVER!
Its not like what I, or anyone, says matters anymore, the giant ball has started rolling. Maybe I should look into becoming an FDA inspector. BangheadBirdDeal

No oversight on the Dr. for the lab work or just in general? What about the State Dental Board?
 
2thm8kr

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No oversight on the Dr. for the lab work or just in general? What about the State Dental Board?
They don't get to that (dental board, court) until they have been through peer review.(arbitration)
 
JMN

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No oversight on the Dr. for the lab work or just in general? What about the State Dental Board?
For MDs, you can kill a patient by the most gross misconduct imaginable, and in most states and your license will only be suspended for 3-5 years maximum. That's at the having sex with a nurse while a patient is losing O2 saturation under sedation level. There is even a fancy name for death by doctor. Iatrogenic Death. The only certain way to keep a MD from practicing is jail.

I doubt the bar is much higher for DDS/DMD licensees.
 
doug

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I feel that some where in this discussion is that there is a lot of dental money going to lobbyist to make sure that they are treated with more tenderness than a lab.
 
BobCDT

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This is one of the most absurd things Ive heard in my career. Again, theres no oversight on the dentist! EVER!
Its not like what I, or anyone, says matters anymore, the giant ball has started rolling. Maybe I should look into becoming an FDA inspector. BangheadBirdDeal
I believe there is a board of dental examiners in all states that oversees the dentist. Believe it or not, there are dentists losing their license to practice every year. Generally, they need to kill someone first but it is regulated.
 
BobCDT

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For good or bad, this has become reality for us. It's really interesting, to cut someone's hair one needs to be licensed. To give a massage, same thing. When you think about this, it is strange there has been zero regulation to make someone's teeth.
What's really great, is there is someone like Tim that can help any of us get over the hurdle.
 
Affinity

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The dentist doesnt receive any oversight by a dental board until a complaint has been filed, or multiple, as it has been explained to me. If they do terrible work, its the equivalent of the lube shop giving you 4qts instead of 5.. Even Drs that have gone to court for sexual harassment, they can cover it up with money, thats all I will say.
 
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I will agree with you Bob, what we do is very loosely regulated and maybe thats where the friction begins for me.. its been nice to be an artisan craft dating back to Washingtons dentures. IF we were truly respected, as are labs and techs in Europe, things would be different, but we are a nation of capitalist consumers, this includes dentists, and the almighty dollar rules.

Lower healthcare costs by raising fees and regulations on device manufacturers? Hmmmm2
 
JMN

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For good or bad, this has become reality for us. It's really interesting, to cut someone's hair one needs to be licensed. To give a massage, same thing. When you think about this, it is strange there has been zero regulation to make someone's teeth.
What's really great, is there is someone like Tim that can help any of us get over the hurdle.
Barber licensing is a historical carryover from when the red/white poles were blood soaked bandages hung out to advertise their services as tooth pullers and other things additional to hair modification. That's the most perfect example of a very stupid use of government power from agency preservation existential inertia and financial gain.

Massage licensing is more of a 'make me feel safe' measure so people with recorded histories of sexual assault and similar issues don't set up shop.

Not trying to disagree, it's just that both of those examples are of varying degrees of overreach. I don't fully disagree. I just really don't like it that we are being held to a different standard than the D average bottom of the class licensee who doesn't care enough to learn the difference between an impression and a pickup impression.

To clarify, I don't want us making D average work, we are being made the quality control layer because they cannot control the practitioners quality. That is what is really the base of my issue with this newer reach from a bunch of FDA revolving door regulator/insider/regulator hypocrites.

Maybe later I'll tell you how I really feel.
 
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