The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Clear Aligner Adhesive.
| Device ID | K123348 |
| 510k Number | K123348 |
| Device Name: | CLEAR ALIGNER ADHESIVE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | RELIANCE ORTHODONTIC PRODUCTS, INC. 1540 WEST THORNDALE AVE. Itasca, IL 60143 |
| Contact | Paula Wendland |
| Correspondent | Paula Wendland RELIANCE ORTHODONTIC PRODUCTS, INC. 1540 WEST THORNDALE AVE. Itasca, IL 60143 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2013-02-28 |
| Summary: | summary |