The following data is part of a premarket notification filed by Dfl Industria E Comercio S.a. with the FDA for Vitro Molar.
| Device ID | K123826 |
| 510k Number | K123826 |
| Device Name: | VITRO MOLAR |
| Classification | Cement, Dental |
| Applicant | DFL INDUSTRIA E COMERCIO S.A. 18851 NE 29TH AVE 720 Aventure, FL 33180 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad DFL INDUSTRIA E COMERCIO S.A. 18851 NE 29TH AVE 720 Aventure, FL 33180 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-12 |
| Decision Date | 2013-02-14 |
| Summary: | summary |