The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Maximum Cure Sealant With Fluoride.
| Device ID | K894566 |
| 510k Number | K894566 |
| Device Name: | MAXIMUM CURE SEALANT WITH FLUORIDE |
| 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 | 1989-07-21 |
| Decision Date | 1989-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D798PJMCFF0 | K894566 | 000 |
| D798PJMCF0 | K894566 | 000 |
| D798MCF7AF0 | K894566 | 000 |
| D798MC7AF0 | K894566 | 000 |
| D798MC20AF0 | K894566 | 000 |