The following data is part of a premarket notification filed by Metalor Dental Usa Corp. with the FDA for Vs11 Sf.
Device ID | K951271 |
510k Number | K951271 |
Device Name: | VS11 SF |
Classification | Alloy, Gold-based Noble Metal |
Applicant | METALOR DENTAL USA CORP. 457 LAUREL RD. BOX 369 Rockville Centre, NY 11571 -0369 |
Contact | Brian F Schiller |
Correspondent | Brian F Schiller METALOR DENTAL USA CORP. 457 LAUREL RD. BOX 369 Rockville Centre, NY 11571 -0369 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-21 |
Decision Date | 1995-06-22 |