The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Ips Empress.
Device ID | K913372 |
510k Number | K913372 |
Device Name: | IPS EMPRESS |
Classification | Powder, 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 | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-29 |
Decision Date | 1991-10-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IPS EMPRESS 74220354 1928460 Live/Registered |
IVOCLAR VIVADENT, INC. 1991-11-12 |