The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Century Model 105c.
Device ID | K093341 |
510k Number | K093341 |
Device Name: | CENTURY MODEL 105C |
Classification | Handpiece, Air-powered, Dental |
Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
Contact | Claudia Ortiz |
Correspondent | Claudia Ortiz SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-10-23 |
Decision Date | 2010-04-05 |
Summary: | summary |