The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Sealapex.
| Device ID | K944480 |
| 510k Number | K944480 |
| Device Name: | SEALAPEX |
| 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 | 1994-09-13 |
| Decision Date | 1994-11-03 |