The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Flowtain & Flowtain Lv.
| Device ID | K083051 |
| 510k Number | K083051 |
| Device Name: | FLOWTAIN & FLOWTAIN LV |
| 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 | 2008-10-14 |
| Decision Date | 2009-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D798FTLV0 | K083051 | 000 |
| D798FT0 | K083051 | 000 |
| D7981FTLV0 | K083051 | 000 |
| D7981FT0 | K083051 | 000 |