The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Silicoater Md.
Device ID | K910719 |
510k Number | K910719 |
Device Name: | SILICOATER MD |
Classification | Cement, Dental |
Applicant | KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine, CA 92718 |
Contact | Sharon Parker |
Correspondent | Sharon Parker KULZER, INC. 10005 MUIRLANDS BLVD. UNIT G. Irvine, CA 92718 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-20 |
Decision Date | 1991-04-29 |