The following data is part of a premarket notification filed by 3m Company with the FDA for 3m True Definition Scanner.
| Device ID | K122467 |
| 510k Number | K122467 |
| Device Name: | 3M TRUE DEFINITION SCANNER |
| Classification | System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations |
| Applicant | 3M COMPANY 2510 CONWAY AVENUE St. Paul, MN 55144 |
| Contact | Ginger Cantor |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NOF |
| CFR Regulation Number | 872.3661 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-08-13 |
| Decision Date | 2012-11-20 |
| Summary: | summary |