The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Rely-a-bond W/fluoride (no Mix Adhesive).
| Device ID | K895521 |
| 510k Number | K895521 |
| Device Name: | RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE) |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | RELIANCE ORTHODONTIC PRODUCTS, INC. P.O. BOX 678 Itasca, IL 60143 |
| Contact | Paul Gange |
| Correspondent | Paul Gange RELIANCE ORTHODONTIC PRODUCTS, INC. P.O. BOX 678 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 | 1989-09-12 |
| Decision Date | 1989-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D82813306120 | K895521 | 000 |
| D798RPTHINF0 | K895521 | 000 |
| D798RPRF0 | K895521 | 000 |
| D798RPF0 | K895521 | 000 |
| D798RJF0 | K895521 | 000 |
| D798BIRPRF8GM0 | K895521 | 000 |
| D798BIRPF0 | K895521 | 000 |
| D79816GRPRF0 | K895521 | 000 |