DENTHESIVE
Agent, Tooth Bonding, Resin
KULZER, INC.
The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Denthesive.
Pre-market Notification Details
| Device ID | K905302 |
| 510k Number | K905302 |
| Device Name: | DENTHESIVE |
| Classification | Agent, Tooth Bonding, Resin |
| 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-28 |
| Decision Date | 1991-02-26 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660398620 | K905302 | 000 |
Trademark Results [DENTHESIVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DENTHESIVE 74140569 1742675 Dead/Cancelled |
HERAEUS KULZER GMBH 1991-02-19 |
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