The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Led Pro Seal.
| Device ID | K073243 |
| 510k Number | K073243 |
| Device Name: | LED PRO SEAL |
| Classification | Coating, Filling Material, 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 | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-19 |
| Decision Date | 2008-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D798LEDPRO0 | K073243 | 000 |