The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Sci-pharm Orthodontic Adhesive.
| Device ID | K791132 |
| 510k Number | K791132 |
| Device Name: | SCI-PHARM ORTHODONTIC ADHESIVE |
| 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 | 1979-06-18 |
| Decision Date | 1979-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816526021678 | K791132 | 000 |
| D801SP65024B1 | K791132 | 000 |
| D801SP650241 | K791132 | 000 |
| D801SP65023SB1 | K791132 | 000 |
| D801SP65023B1 | K791132 | 000 |
| D801SP650231 | K791132 | 000 |
| D801SP65022B1 | K791132 | 000 |
| D801SP650221 | K791132 | 000 |
| D801SP65021N1 | K791132 | 000 |
| D801SP65021B1 | K791132 | 000 |
| D801SP65021 | K791132 | 000 |
| D801ID6602I1 | K791132 | 000 |
| D801ID6512I1 | K791132 | 000 |
| D801ID65024I1 | K791132 | 000 |
| D801SP65028C1 | K791132 | 000 |
| D801SP6502S1 | K791132 | 000 |
| D801SP65121 | K791132 | 000 |
| 00816526021661 | K791132 | 000 |
| 00816526021319 | K791132 | 000 |
| 00816526021302 | K791132 | 000 |
| 00816526021272 | K791132 | 000 |
| D801SP67028N1 | K791132 | 000 |
| D801SP67021 | K791132 | 000 |
| D801SP6602S1 | K791132 | 000 |
| D801SP66021 | K791132 | 000 |
| D801SP6512S1 | K791132 | 000 |
| D801SP65126B1 | K791132 | 000 |
| D801SP651261 | K791132 | 000 |
| D801SP65121N1 | K791132 | 000 |
| D801SP65121B1 | K791132 | 000 |
| D801ID65021I1 | K791132 | 000 |