The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Fillock Reamer.
Device ID | K901097 |
510k Number | K901097 |
Device Name: | FILLOCK REAMER |
Classification | Drill, Dental, Intraoral |
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 | DZA |
CFR Regulation Number | 872.4130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-07 |
Decision Date | 1990-04-25 |