The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Reliance S.e.p..
| Device ID | K071688 |
| 510k Number | K071688 |
| Device Name: | RELIANCE S.E.P. |
| Classification | Agent, Tooth Bonding, 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-20 |
| Decision Date | 2007-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D82813302550 | K071688 | 000 |
| D798SEPR0 | K071688 | 000 |
| D798SEPPRO0 | K071688 | 000 |
| D798SEPD0 | K071688 | 000 |
| D798SEPC0 | K071688 | 000 |