The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Sealapex 4.
| Device ID | K010940 |
| 510k Number | K010940 |
| Device Name: | SEALAPEX 4 |
| Classification | Resin, Root Canal Filling |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-29 |
| Decision Date | 2001-06-20 |