The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Kerr Hard Denture Reline Material.
| Device ID | K981448 |
| 510k Number | K981448 |
| Device Name: | KERR HARD DENTURE RELINE MATERIAL |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
| Contact | Wendy A Urtel |
| Correspondent | Wendy A Urtel SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-22 |
| Decision Date | 1998-06-16 |
| Summary: | summary |