The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Curay-eclipse Visible Light Cured Ortho.
| Device ID | K831495 |
| 510k Number | K831495 |
| Device Name: | CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-10 |
| Decision Date | 1983-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816526021654 | K831495 | 000 |
| D801SP6005S1 | K831495 | 000 |
| D801SP60055B1 | K831495 | 000 |
| D801SP600551 | K831495 | 000 |
| D801SP60054N1 | K831495 | 000 |
| D801SP60054B1 | K831495 | 000 |
| D801SP60053CB1 | K831495 | 000 |
| D801SP60053C1 | K831495 | 000 |
| D801SP60052N1 | K831495 | 000 |
| D801SP60052B1 | K831495 | 000 |
| D801SP60051N1 | K831495 | 000 |
| D801SP60051B1 | K831495 | 000 |
| D801SP60051 | K831495 | 000 |
| D801ID6005I1 | K831495 | 000 |
| D801ID60052I1 | K831495 | 000 |
| D801ID60051I1 | K831495 | 000 |
| 00190746134296 | K831495 | 000 |
| D801SP60151 | K831495 | 000 |
| 00190707047818 | K831495 | 000 |
| 00190746000010 | K831495 | 000 |
| 00816526021647 | K831495 | 000 |
| 00816526021630 | K831495 | 000 |
| 00816526021289 | K831495 | 000 |
| 00190746134098 | K831495 | 000 |
| 00190746134081 | K831495 | 000 |
| 00190746007743 | K831495 | 000 |
| 00190746007736 | K831495 | 000 |
| 00190746007729 | K831495 | 000 |
| 00190746007712 | K831495 | 000 |
| 00190746007705 | K831495 | 000 |
| 00190746007699 | K831495 | 000 |
| 00190746007682 | K831495 | 000 |
| 00190746007675 | K831495 | 000 |
| 00190746007668 | K831495 | 000 |
| 00190746007651 | K831495 | 000 |
| 00190746000027 | K831495 | 000 |
| 00190746059254 | K831495 | 000 |