The following data is part of a premarket notification filed by Metalor Dental Usa Corp. with the FDA for Sura Snap.
Device ID | K924155 |
510k Number | K924155 |
Device Name: | SURA SNAP |
Classification | Implant, Endosseous, Root-form |
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 | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-18 |
Decision Date | 1993-05-12 |