The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Kerr Gel Etchant.
| Device ID | K000954 |
| 510k Number | K000954 |
| Device Name: | KERR GEL ETCHANT |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Contact | Orlando Tadeo, Jr. |
| Correspondent | Orlando Tadeo, Jr. SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-24 |
| Decision Date | 2000-04-28 |