The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Light-cured Orthodontic Band Cement.
| Device ID | K001446 |
| 510k Number | K001446 |
| Device Name: | LIGHT-CURED ORTHODONTIC BAND CEMENT |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
| Contact | Jan A Orlowski |
| Correspondent | Jan A Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-08 |
| Decision Date | 2000-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816526021296 | K001446 | 000 |
| 00190746007880 | K001446 | 000 |
| D801SP62011N1 | K001446 | 000 |
| D801SP62011B1 | K001446 | 000 |
| D801SP62011 | K001446 | 000 |