The following data is part of a premarket notification filed by Midatlantic Division Of Dentrex, Inc. with the FDA for Vision Esthetic Porcelain System.
| Device ID | K000680 |
| 510k Number | K000680 |
| Device Name: | VISION ESTHETIC PORCELAIN SYSTEM |
| Classification | Powder, Porcelain |
| Applicant | MIDATLANTIC DIVISION OF DENTREX, INC. 600 DEER RD. SUITE 3 Cherry Hill, NJ 08034 |
| Contact | Laurance W Powell |
| Correspondent | Laurance W Powell MIDATLANTIC DIVISION OF DENTREX, INC. 600 DEER RD. SUITE 3 Cherry Hill, NJ 08034 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-29 |
| Decision Date | 2000-05-25 |