The following data is part of a premarket notification filed by Temrex Corp. with the FDA for Temrex-dentin Varnish.
| Device ID | K851030 |
| 510k Number | K851030 |
| Device Name: | TEMREX-DENTIN VARNISH |
| Classification | Varnish, Cavity |
| Applicant | TEMREX CORP. SCIENTIFIC PHARMACEUTICALS, IN 1828 EVERGREEN STREET Duarte, CA 91010 |
| Contact | Jan Orlowski |
| Correspondent | Jan Orlowski TEMREX CORP. SCIENTIFIC PHARMACEUTICALS, IN 1828 EVERGREEN STREET Duarte, CA 91010 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-12 |
| Decision Date | 1985-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850015110306 | K851030 | 000 |
| 00850015110283 | K851030 | 000 |
| 00850015110290 | K851030 | 000 |