The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Cosmopost.
Device ID | K972875 |
510k Number | K972875 |
Device Name: | COSMOPOST |
Classification | Post, Root Canal |
Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Peter P Mancuso |
Correspondent | Peter P Mancuso IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | ELR |
CFR Regulation Number | 872.3810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-04 |
Decision Date | 1997-09-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COSMOPOST 75345595 2232986 Live/Registered |
IVOCLAR VIVADENT AG 1997-08-22 |