The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Ips Ceramic Etching Gel.
| Device ID | K923926 |
| 510k Number | K923926 |
| Device Name: | IPS CERAMIC ETCHING GEL |
| Classification | Teeth, Porcelain |
| Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Lloyd V Ziemendorf |
| Correspondent | Lloyd V Ziemendorf IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | ELL |
| CFR Regulation Number | 872.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-05 |
| Decision Date | 1992-10-27 |