The following data is part of a premarket notification filed by Discus Dental Inc. with the FDA for Relief Acp Oral Care Gel.
| Device ID | K062176 |
| 510k Number | K062176 |
| Device Name: | RELIEF ACP ORAL CARE GEL |
| Classification | Varnish, Cavity |
| Applicant | DISCUS DENTAL INC. 8550 HIGUERA ST. Culver City, CA 90232 |
| Contact | Steven L Ziemba |
| Correspondent | Steven L Ziemba DISCUS DENTAL INC. 8550 HIGUERA ST. Culver City, CA 90232 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-31 |
| Decision Date | 2007-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00075020065469 | K062176 | 000 |
| 00075020043900 | K062176 | 000 |
| 00075020043863 | K062176 | 000 |
| 00075020035004 | K062176 | 000 |
| 00075020034991 | K062176 | 000 |
| 00075020034403 | K062176 | 000 |
| 00075020034311 | K062176 | 000 |
| 08710103632061 | K062176 | 000 |
| 00075020089892 | K062176 | 000 |