The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Tubli-seal Ewt.
| Device ID | K942393 |
| 510k Number | K942393 |
| Device Name: | TUBLI-SEAL EWT |
| Classification | Resin, Root Canal Filling |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Contact | Jeffrey A Anderson |
| Correspondent | Jeffrey A Anderson SYBRON DENTAL SPECIALTIES, INC. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-19 |
| Decision Date | 1994-06-10 |