The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for No-mix 30 Orthodontic Bonding System, Plastic.
| Device ID | K890834 |
| 510k Number | K890834 |
| Device Name: | NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Contact | A Orlowski |
| Correspondent | A Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-21 |
| Decision Date | 1989-05-01 |