The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Temrex Etching Gel.
| Device ID | K872569 |
| 510k Number | K872569 |
| Device Name: | TEMREX ETCHING GEL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Contact | Jan A Orlowski |
| Correspondent | Jan A Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-29 |
| Decision Date | 1987-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190746007828 | K872569 | 000 |
| D801SP70130B1 | K872569 | 000 |
| D801SP7012SB1 | K872569 | 000 |
| D801SP7012RB1 | K872569 | 000 |
| D801SP7012N1 | K872569 | 000 |
| D801SP7012B1 | K872569 | 000 |
| D801SP70128B1 | K872569 | 000 |
| D801SP70125SB1 | K872569 | 000 |
| D801SP70125RB1 | K872569 | 000 |
| D801SP70125N1 | K872569 | 000 |
| D801SP70125B1 | K872569 | 000 |
| D801SP701211 | K872569 | 000 |
| D801SP50118N1 | K872569 | 000 |
| D801SP50013N1 | K872569 | 000 |
| D801SP50013B1 | K872569 | 000 |
| D801ID70125BI1 | K872569 | 000 |
| 00190746059247 | K872569 | 000 |
| D801SP70130N1 | K872569 | 000 |
| D801SP70143B1 | K872569 | 000 |
| D801SP70143N1 | K872569 | 000 |
| 00190746007811 | K872569 | 000 |
| 00190746007804 | K872569 | 000 |
| 00190707000691 | K872569 | 000 |
| 00190746136870 | K872569 | 000 |
| 00190746136863 | K872569 | 000 |
| 00190746134753 | K872569 | 000 |
| 00850015110429 | K872569 | 000 |
| 00850015110412 | K872569 | 000 |
| 00850015110405 | K872569 | 000 |
| 00850015110399 | K872569 | 000 |
| 00850015110382 | K872569 | 000 |
| 00850015110375 | K872569 | 000 |
| 00850015110320 | K872569 | 000 |
| 00850015110092 | K872569 | 000 |
| D801SP7014N1 | K872569 | 000 |
| D801SP7014B1 | K872569 | 000 |
| 00190746059230 | K872569 | 000 |