The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Phase Ii Orthodontic Adhesive.
| Device ID | K895523 |
| 510k Number | K895523 |
| Device Name: | PHASE II ORTHODONTIC ADHESIVE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | RELIANCE ORTHODONTIC PRODUCTS, INC. P.O. BOX 678 Itasca, IL 60143 |
| Contact | Paul A Gange |
| Correspondent | Paul A 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 | 1989-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D798PJAF0 | K895523 | 000 |
| 00840479202389 | K895523 | 000 |
| 00840479202396 | K895523 | 000 |
| 00840479202426 | K895523 | 000 |
| 00840479202570 | K895523 | 000 |
| D7981PSA0 | K895523 | 000 |
| D7981PSAF0 | K895523 | 000 |
| D798PEJF0 | K895523 | 000 |
| D798PESF0 | K895523 | 000 |
| D798PJA0 | K895523 | 000 |
| 00840479202372 | K895523 | 000 |