The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Beauticem Sa.
| Device ID | K120159 |
| 510k Number | K120159 |
| Device Name: | BEAUTICEM SA |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-19 |
| Decision Date | 2012-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23532140 | K120159 | 000 |
| E23532130 | K120159 | 000 |