The following data is part of a premarket notification filed by Espe Gmbh (us) with the FDA for Ketac-glaze.
| Device ID | K884752 |
| 510k Number | K884752 |
| Device Name: | KETAC-GLAZE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Contact | Harold A Opotow |
| Correspondent | Harold A Opotow ESPE GMBH (US) 200 LAKE AVENUE (#205) Lake Worth, FL 33460 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-14 |
| Decision Date | 1989-01-19 |