The following data is part of a premarket notification filed by Cooley Consulting, Inc. with the FDA for Silver Dental Arrest.
| Device ID | K102973 |
| 510k Number | K102973 |
| Device Name: | SILVER DENTAL ARREST |
| Classification | Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| Applicant | COOLEY CONSULTING, INC. 531 CHISHOLM TRAIL Wyoming, OH 45215 |
| Contact | William Cooley |
| Correspondent | William Cooley COOLEY CONSULTING, INC. 531 CHISHOLM TRAIL Wyoming, OH 45215 |
| Product Code | PHR |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-06 |
| Decision Date | 2014-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858290006130 | K102973 | 000 |
| 00858290006000 | K102973 | 000 |
| 00858290006161 | K102973 | 000 |
| 00858290006611 | K102973 | 000 |
| 00858290006604 | K102973 | 000 |
| 00858290006888 | K102973 | 000 |