The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Pontic Paint.
| Device ID | K130237 |
| 510k Number | K130237 |
| Device Name: | PONTIC PAINT |
| Classification | Aligner, Sequential |
| 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 | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-31 |
| Decision Date | 2013-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D798PPD30 | K130237 | 000 |
| D798PASM0 | K130237 | 000 |
| D798PPA20 | K130237 | 000 |
| D798PPA30 | K130237 | 000 |
| D798PPB10 | K130237 | 000 |
| D798PPA10 | K130237 | 000 |
| D798PPA350 | K130237 | 000 |
| D798PPBL0 | K130237 | 000 |
| D798PPC10 | K130237 | 000 |
| D798PPC40 | K130237 | 000 |
| D798PASL0 | K130237 | 000 |