The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Prg Barrier Coat.
| Device ID | K122908 |
| 510k Number | K122908 |
| Device Name: | PRG BARRIER COAT |
| Classification | Varnish, Cavity |
| Applicant | SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos, CA 92078 |
| Contact | David P Morais |
| Correspondent | David P Morais SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos, CA 92078 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-21 |
| Decision Date | 2013-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23517950 | K122908 | 000 |
| E23517860 | K122908 | 000 |
| E235Y29100 | K122908 | 000 |