I'm DDS that wants to start a niche lab and I need help.

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HawkeyeDDS

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I'm a 38yo DDS and in the depths of the pandemic, I hatched a plan to start a dental lab. I would like to start a mini dental lab and solely focus on implant planning, surgical guide fabrication (for fully guided surgery) and associated custom healing abutments/temporary crowns. Why? 2 reasons:

#1 - I have some health issues that are forcing me to decrease my time chairside.
#2 - I know that at least locally, the surgeons could get a lot better final result if they went fully guided.

I don't care to make this a big thing and I hope to keep just a few local clients. I can use my lab space in my existing office that I own. I have a 3Shape IO scanner and a SprintRay printer so I am familiar with the digital realm. I believe I will use 3Shape software for the planning and guide design, and I already have a souped up computer to handle it. I have a few burning questions:

What formalities are there to starting a dental lab business? Do I need to register with the FDA to sell a class I device? Do I have to register with the state?

I notice that a lot of labs are not doing this, what is holding them back?
 
CatamountRob

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Some of what you are asking is dependent on what state you’re located in. Are you in Iowa?
 
Jo Chen

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I don’t think Wisconsin has any specific licensing requirements for labs like Texas. Get a business license if this endeavor is a different entity from your dentist office and start telling your colleagues about your service
 
CoolHandLuke

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Do I need to register with the FDA to sell a class I device
only if you intended to design and build your own brand of device instead of follow established procedures and workflows wrt materials and manufacturing.

if you just want to make prosthetics, no. just be a lab.
 
Toothman19

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I'm a 38yo DDS and in the depths of the pandemic, I hatched a plan to start a dental lab. I would like to start a mini dental lab and solely focus on implant planning, surgical guide fabrication (for fully guided surgery) and associated custom healing abutments/temporary crowns. Why? 2 reasons:

#1 - I have some health issues that are forcing me to decrease my time chairside.
#2 - I know that at least locally, the surgeons could get a lot better final result if they went fully guided.

I don't care to make this a big thing and I hope to keep just a few local clients. I can use my lab space in my existing office that I own. I have a 3Shape IO scanner and a SprintRay printer so I am familiar with the digital realm. I believe I will use 3Shape software for the planning and guide design, and I already have a souped up computer to handle it. I have a few burning questions:

What formalities are there to starting a dental lab business? Do I need to register with the FDA to sell a class I device? Do I have to register with the state?

I notice that a lot of labs are not doing this, what is holding them back?
Have you looked into hiring an associate? All surgeons would get a better result from guided surgery, but most are too cheap to pay for it
 
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HawkeyeDDS

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Thanks for the input.

I'm also wondering if other dental labs would find it beneficial to have a DDS do implant planning for them? Then they could manufacture and sell the guide?
 
Affinity

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You might try talking to blue sky bio, they have dentists on staff that do implant planning. Might be a way to see if you actually want to sit in front of a computer part of the day. Trying to compete with BSB and every other dental company that offers this is tough unless you have some connections to a few surgeons that could send cases.
 
prosthotech

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I am a 46yo DDS and JD west of Chicago. I have had my own in house lab in some form or another for over 18 years. First of all, before going down this path, decide what you are doing this for, and what you expect to get from it. Our lab provides all of the solutions you mentioned, as well as, some "traditional" prosthetic solutions to outside dentists. Over the years I learned a few things. I started my lab out of necessity in the early 2000's mainly because I loved making my own gold castings, and then from the sad state of implant expertise at the time, from even the bigger labs. While we are in the black most months, making a profit was secondary to producing complex implant work, which has become greatly simplified with digital design (as opposed to laser welding, vacuum casting and miscasting, etc.)

My 2 cents...if you are striving to be the best at cosmetics or implants, then opening a lab can be worthwhile. Being able to produce the work from model work to final occlusal adjustments is both satisfying and enlightening. I know that my experiences and knowledge regarding techniques and limitations of dental laboratory technology has made me a better dentist. Also, it helps to love to do lab work.

If you are opening a lab to supplement you income, unless you are familiar with the business, I would reconsider and invest in a popular franchise instead. The amount of owner involvement in the early days of your lab will be significant. You will be married to the lab and will have to limit vacations to 3 day weekends. I'm still scarred from the multiple all-nighters that were required to meet a deadline. Bill collecting can be challenging, but poor cash flow is more significant that a dental office, since the profit margins are much tighter. Finally, you will need a unique marketing approach to compete with existing labs.

Just curious, have you spend time at a bench in a dental lab before?


I'm a 38yo DDS and in the depths of the pandemic, I hatched a plan to start a dental lab. I would like to start a mini dental lab and solely focus on implant planning, surgical guide fabrication (for fully guided surgery) and associated custom healing abutments/temporary crowns. Why? 2 reasons:

#1 - I have some health issues that are forcing me to decrease my time chairside.
#2 - I know that at least locally, the surgeons could get a lot better final result if they went fully guided.

I don't care to make this a big thing and I hope to keep just a few local clients. I can use my lab space in my existing office that I own. I have a 3Shape IO scanner and a SprintRay printer so I am familiar with the digital realm. I believe I will use 3Shape software for the planning and guide design, and I already have a souped up computer to handle it. I have a few burning questions:

What formalities are there to starting a dental lab business? Do I need to register with the FDA to sell a class I device? Do I have to register with the state?

I notice that a lot of labs are not doing this, what is holding them back?
 
prosthotech

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What formalities are there to starting a dental lab business? Do I need to register with the FDA to sell a class I device? Do I have to register with the state?

I notice that a lot of labs are not doing this, what is holding them back?

Depends on your state, county, and city. Most states don't require anything unless you are organizing a corp, LLC or dba. You will have to use a plaster trap, have adequate ventilation and air quality, and have an infection control and exposure protocols in place for incoming cases. If you have driver, you will have to have proper liability coverage for them and the vehicle. FDA only if you are producing whole implant abutments including prosthetic interface, for sleep apnea appliances, and imported work. However, as a licensed dentist, you may fall under exemptions for FDA registration. I'm sure there are ramifications to non-registration, so as with all legal matters, you should consult with a local attorney regarding questions of the law.

FDA registration is relatively expensive (depending on the size of your lab),will require additional paperwork and other office time, and opens up your premises to inspection authority from yet another state or federal agency. Most labs do not make whole custom abutments, and instead use pre-milled blanks, which have the prosthetic connection already made on a heavier mill. By the way, custom abutment made or modified by hand don't require FDA registration.
 
bigj1972

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I am a 46yo DDS and JD west of Chicago. I have had my own in house lab in some form or another for over 18 years. First of all, before going down this path, decide what you are doing this for, and what you expect to get from it. Our lab provides all of the solutions you mentioned, as well as, some "traditional" prosthetic solutions to outside dentists. Over the years I learned a few things. I started my lab out of necessity in the early 2000's mainly because I loved making my own gold castings, and then from the sad state of implant expertise at the time, from even the bigger labs. While we are in the black most months, making a profit was secondary to producing complex implant work, which has become greatly simplified with digital design (as opposed to laser welding, vacuum casting and miscasting, etc.)

My 2 cents...if you are striving to be the best at cosmetics or implants, then opening a lab can be worthwhile. Being able to produce the work from model work to final occlusal adjustments is both satisfying and enlightening. I know that my experiences and knowledge regarding techniques and limitations of dental laboratory technology has made me a better dentist. Also, it helps to love to do lab work.

If you are opening a lab to supplement you income, unless you are familiar with the business, I would reconsider and invest in a popular franchise instead. The amount of owner involvement in the early days of your lab will be significant. You will be married to the lab and will have to limit vacations to 3 day weekends. I'm still scarred from the multiple all-nighters that were required to meet a deadline. Bill collecting can be challenging, but poor cash flow is more significant that a dental office, since the profit margins are much tighter. Finally, you will need a unique marketing approach to compete with existing labs.

Just curious, have you spend time at a bench in a dental lab before?
Thank you Doctor. An excellent, informative post.
 
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You'll figure out why.
Good luck anyway.
:Top:
I'd rather not figure out why after the fact. That's why I am asking all of you :) I'd also rather not rely on luck. So what is it? Are surgical guides not profitable enough?
 
bigj1972

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I'd rather not figure out why after the fact. That's why I am asking all of you :) I'd also rather not rely on luck. So what is it? Are surgical guides not profitable enough?
Well, in my experience, some general dentists don't wanna pay for it. (Unless its $75.00). The other excellent clinicians who require one and pay a few hundred to have one made, they send it to OS, and they leave it on the counter. ("Eyeball it"). Those OS that know its importance have embraced the technology, and fabricate their own.

Dr. Kim gave excellent advice above. 👆
 
Andrew Priddy

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Most Drs I've worked with won't use/order guides, simply because its an added cost... it wouldn't be profitable at all, or better said, I couldn't make a living if that's all I did. (in my area) IMO, you would need a "far reach".

with that said, what about the cost?
3Shape/scanner 16,500
print/mill/outsource manufacturing?
 
Car 54

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And believe it or not, I'm still doing the wax up, suck down, fill with acrylic type of guides. I just sent 2 quadrants out to my main account (his wife's case) for him to send to the oral surgeon. The oral surgeon seems to like them, as it's a small town and I asked for his feedback on improving them.
 

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