The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Sr-ivocap.
Device ID | K896130 |
510k Number | K896130 |
Device Name: | SR-IVOCAP |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
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 | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-23 |
Decision Date | 1990-04-16 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SR-IVOCAP 73261259 1250192 Live/Registered |
Ivoclar AG 1980-05-08 |