The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Shofu Mz Primer Plus.
Device ID | K172106 |
510k Number | K172106 |
Device Name: | SHOFU MZ Primer Plus |
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 | 2017-07-12 |
Decision Date | 2017-08-31 |