510(k) K093341

CENTURY MODEL 105C by Sybron Dental Specialties, Inc. — Product Code EFB

K093341 is an FDA 510(k) premarket notification submitted by Sybron Dental Specialties, Inc. for the device "CENTURY MODEL 105C". The FDA issued a decision of Substantially Equivalent on April 5, 2010. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Sybron Dental Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2010
Date Received
October 23, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type