The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Image Fast Set, Image Regular Set.
| Device ID | K160097 |
| 510k Number | K160097 |
| Device Name: | Image Fast Set, Image Regular Set |
| Classification | Material, Impression |
| Applicant | Sybron Dental Specialties 1717 W. Collins Ave Orange, CA 92867 |
| Contact | Gerardo Lara |
| Correspondent | Gerardo Lara Sybron Dental Specialties 1717 W. Collins Ave Orange, CA 92867 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814978023810 | K160097 | 000 |
| 10814978023803 | K160097 | 000 |
| 10814978023797 | K160097 | 000 |
| 10814978023780 | K160097 | 000 |
| 10814978023766 | K160097 | 000 |
| 10814978023728 | K160097 | 000 |
| 00814978023387 | K160097 | 000 |
| 00814978023370 | K160097 | 000 |
| 00814978021413 | K160097 | 000 |