The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Ceraresin Bond.
| Device ID | K123119 |
| 510k Number | K123119 |
| Device Name: | CERARESIN BOND |
| Classification | Agent, Tooth Bonding, Resin |
| 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-03 |
| Decision Date | 2012-11-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23517410 | K123119 | 000 |
| E23517390 | K123119 | 000 |