The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Hc Primer.
| Device ID | K161891 |
| 510k Number | K161891 |
| Device Name: | HC Primer |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | Shofu Dental Corporation 1225 Stone Drive San Marcos, CA 92078 |
| Contact | Mauro Malzyner |
| Correspondent | Mauro Malzyner 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 | 2016-07-11 |
| Decision Date | 2016-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E235Y00050 | K161891 | 000 |