The following data is part of a premarket notification filed by Ivoclar Usa, Inc. with the FDA for Provipont C&b.
Device ID | K941849 |
510k Number | K941849 |
Device Name: | PROVIPONT C&B |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | IVOCLAR USA, INC. 175 PINEVIEW DR. Amherst, NY 14150 |
Contact | Lloyd V Ziemendorf |
Correspondent | Lloyd V Ziemendorf IVOCLAR USA, INC. 175 PINEVIEW DR. Amherst, NY 14150 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-14 |
Decision Date | 1994-08-17 |