The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Pulp Canal Sealer, Pulp Canal Sealer Ewt.
| Device ID | K152956 |
| 510k Number | K152956 |
| Device Name: | Pulp Canal Sealer, Pulp Canal Sealer EWT |
| Classification | Resin, Root Canal Filling |
| Applicant | SYBRON DENTAL SPECIALTIES 1717 W. COLLINS AVE. Orange, CA 92867 |
| Contact | Courtney Clark |
| Correspondent | Wendy Garman SYBRON DENTAL SPECIALTIES 1717 W. 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 | 2015-10-07 |
| Decision Date | 2016-05-06 |
| Summary: | summary |