The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Try-in Gel.
| Device ID | K954643 |
| 510k Number | K954643 |
| Device Name: | TRY-IN GEL |
| Classification | Cement, Dental |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Contact | Jeffery A Anderson |
| Correspondent | Jeffery A Anderson SYBRON DENTAL SPECIALTIES, INC. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-10 |
| Decision Date | 1995-10-19 |