The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Teledyne Getz Barrier-dentin Sealer.
| Device ID | K852756 |
| 510k Number | K852756 |
| Device Name: | TELEDYNE GETZ BARRIER-DENTIN SEALER |
| Classification | Varnish, Cavity |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Contact | Jan Orlowski |
| Correspondent | Jan Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. 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 | 1985-06-28 |
| Decision Date | 1985-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D686423053 | K852756 | 000 |