The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Sr-isosit Spectra Link System.
Device ID | K910069 |
510k Number | K910069 |
Device Name: | SR-ISOSIT SPECTRA LINK SYSTEM |
Classification | Agent, Tooth Bonding, Resin |
Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Gary L Severance |
Correspondent | Gary L Severance IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-09 |
Decision Date | 1992-03-02 |