The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Enamel Prep Enamel Etchant (email-preparator Gs).
Device ID | K896132 |
510k Number | K896132 |
Device Name: | ENAMEL PREP ENAMEL ETCHANT (EMAIL-PREPARATOR GS) |
Classification | Material, Tooth Shade, Resin |
Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | L Severance,dds |
Correspondent | L Severance,dds IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-23 |
Decision Date | 1990-01-10 |