The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Zone, Zonefree, Zone A1.
| Device ID | K151526 |
| 510k Number | K151526 |
| Device Name: | Zone, ZoneFree, Zone A1 |
| Classification | Cement, Dental |
| Applicant | SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVENUE Orange, CA 92867 |
| Contact | Courtney Clark |
| Correspondent | Courtney Clark SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVENUE Orange, CA 92867 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-08 |
| Decision Date | 2015-09-10 |
| Summary: | summary |