The following data is part of a premarket notification filed by Medental Intl. with the FDA for Chemical Cure Composite With Enamel Bond.
| Device ID | K982191 |
| 510k Number | K982191 |
| Device Name: | CHEMICAL CURE COMPOSITE WITH ENAMEL BOND |
| Classification | Material, Tooth Shade, Resin |
| Applicant | MEDENTAL INTL. 1246 CLEAR CREEK RD. Evergreen, CO 80434 |
| Contact | Debra Olson |
| Correspondent | Debra Olson MEDENTAL INTL. 1246 CLEAR CREEK RD. Evergreen, CO 80434 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-22 |
| Decision Date | 1998-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850023750136 | K982191 | 000 |
| 00850023750006 | K982191 | 000 |