The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Artglass & Kevloc.
Device ID | K954115 |
510k Number | K954115 |
Device Name: | ARTGLASS & KEVLOC |
Classification | Material, Tooth Shade, Resin |
Applicant | HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine, CA 92718 -2595 |
Contact | Sharon Parker |
Correspondent | Sharon Parker HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine, CA 92718 -2595 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-31 |
Decision Date | 1995-09-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
J014647142110 | K954115 | 000 |