The following data is part of a premarket notification filed by Zhermack Dental Production with the FDA for Occlufast.
Device ID | K935889 |
510k Number | K935889 |
Device Name: | OCCLUFAST |
Classification | Material, Impression |
Applicant | ZHERMACK DENTAL PRODUCTION VIA BOVAZECCHINO, 100 45021 BADIA POLESINE (rovigo) Italy, IT |
Contact | Monica Martello |
Correspondent | Monica Martello ZHERMACK DENTAL PRODUCTION VIA BOVAZECCHINO, 100 45021 BADIA POLESINE (rovigo) Italy, IT |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-12 |
Decision Date | 1994-08-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OCCLUFAST 75615699 2401385 Live/Registered |
Zhermack S.p.A. 1999-01-05 |