The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Therma-cure.
| Device ID | K071590 |
| 510k Number | K071590 |
| Device Name: | THERMA-CURE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | RELIANCE ORTHODONTIC PRODUCTS, INC. 1540 WEST THORNDALE AVE. Itasca, IL 60143 |
| Contact | Paul Gange |
| Correspondent | Paul Gange 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 | 2007-06-11 |
| Decision Date | 2007-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D798TC0 | K071590 | 000 |