I want a 3D printer mainly for surgical guides, please suggest one

[Beginner]

Any resin that goes into the mouth has to be cleared by the FDA for use. Some classifications are for less than 10 minutes in the mouth (custom trays, guides). The other classification is for anything over that time (dentures, temps, crowns, nightguards, etc).

You can’t just print any resin for use in the mouth or you will be sued for every penny if either a patient, doctor or regulatory body finds out. For printing modes use whatever works but for use in the mouth it has to be a Class lla medical device and your printer and curebox have to be validated for use with that resin. That’s why I stated earlier Keystone does a fantastic job of listing every printer and curebox that works (validated) with their resin.

Can you print surgical guides in a dental lab? I think you can't as it is a medical device as per the FDA definition even you you have the proper resin and printer. Please correct me if I'm wrong. Do labs print surgical guides? How do labs print surgical guides considering that the medical device regulation requires that any medical device has to be manufactured in an FDA approved facility? I've been scratching my head about this issue. (ps I own a small lab and want to print surgical guides).

 

[mightymouse]

Can you print surgical guides in a dental lab? I think you can't as it is a medical device as per the FDA definition even you you have the proper resin and printer. Please correct me if I'm wrong. Do labs print surgical guides? How do labs print surgical guides considering that the medical device regulation requires that any medical device has to be manufactured in an FDA approved facility? I've been scratching my head about this issue. (ps I own a small lab and want to print surgical guides).

I currently don’t print surgical guides. There are others that do who can chime in on the specifics of that.

Generally all resins for dental lab side have to be…
1) FDA approved for use in the mouth
2) Be 510K cleared
3) Must use approved printer and post-cure (curebox) workflow.

In terms of being on a list of FDA approved labs for fabrication of a surgical guide I’m not too sure. I think the confusion comes when your fabrication sleep apnea or snore devices digitally. Legally I’m assuming that may be a more trickery road.

I did hear from my annual health and safety class that this is something you want to make sure you’re certified or using the certified process. In all honesty I haven’t seen a class promoting a licensed named sleep apnea product in which you can design digitally and 3D fabricate. But I do know people have designed and 3D fabricate them.

Hopefully others can speak on this whole “FDA Listed Lab” part as I’m not sure one way or the other. Good luck.

 

[bigj1972]

Apnea devices yes, surgical guides I don't think so.
A sleep device is a Treatment appliance, a guide is a tool used to complete a treatment.

 

[Foggy_in_RI]

From: https://www.aegisdentalnetwork.com/idt/2020/02/fda-expands-laboratory-requirements

Accessories: Implant, Dental, Endosseous​

This product classification includes surgical guides for dental implants and this modification will definitely have an impact on printed or milled surgical guides. The FDA added a note to the product classification to the Product Code NDP2stating that a dental laboratory or a surgical guide service provider must "register their establishment" and operate under a Quality Management System. This is the modification that occurred without "written guidance" for the industry to prepare for the change. In communications, the FDA Division of Industry and Consumer Education (DICE) specifically directed the author that the manufacturer of a CAD/CAM Class 1 dental implant surgical guide would be regulated as a device manufacturer and required to comply with the FDA requirements, including having to register their establishment, listing their product,3 and needing to follow the Quality System (QS) regulation.

 

[bigj1972]

From: https://www.aegisdentalnetwork.com/idt/2020/02/fda-expands-laboratory-requirements

Accessories: Implant, Dental, Endosseous​

This product classification includes surgical guides for dental implants and this modification will definitely have an impact on printed or milled surgical guides. The FDA added a note to the product classification to the Product Code NDP2stating that a dental laboratory or a surgical guide service provider must "register their establishment" and operate under a Quality Management System. This is the modification that occurred without "written guidance" for the industry to prepare for the change. In communications, the FDA Division of Industry and Consumer Education (DICE) specifically directed the author that the manufacturer of a CAD/CAM Class 1 dental implant surgical guide would be regulated as a device manufacturer and required to comply with the FDA requirements, including having to register their establishment, listing their product,3 and needing to follow the Quality System (QS) regulation.

Oh well, if you wanna make guides, get out the checkbook for the protection money.