The following data is part of a premarket notification filed by Reliance Orthodontic Products, Inc. with the FDA for Reliance Light Cure Retainer Acrylic.
| Device ID | K894564 |
| 510k Number | K894564 |
| Device Name: | RELIANCE LIGHT CURE RETAINER ACRYLIC |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-21 |
| Decision Date | 1989-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D798LCRET0 | K894564 | 000 |
| D82815308650 | K894564 | 000 |
| D8281330621 | K894564 | 000 |
| D798LCRT51 | K894564 | 000 |
| D798LCREP0 | K894564 | 000 |
| D798LCR150 | K894564 | 000 |
| D798LCR0 | K894564 | 000 |
| D7981LCR150 | K894564 | 000 |