Cleared Traditional

K093341 - CENTURY MODEL 105C

K093341 is an FDA 510(k) clearance for CENTURY MODEL 105C, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K093341 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
164d
Days
Class 1
Risk

K093341 is an FDA 510(k) clearance for the CENTURY MODEL 105C. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on April 5, 2010 after a review of 164 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K093341

510(k) Number K093341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2009
Decision Date April 05, 2010
Days to Decision 164 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 128d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFB Handpiece, Air-powered, Dental

All 250
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K093341.
HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT
K100389 · Handpiece Headquarters · Aug 2010
SYLE SMARTIP
K100833 · Osspray, Ltd. · Jun 2010
DENTAL HANDPIECE
K093971 · North West Medical Instrument (Group) Co., Ltd. · Apr 2010
SAF (SELF ADJUSTING FILE)
K092933 · Redent-Nova , Ltd. · Jan 2010
STARCARE HANDPIECE MAINTENANCE UNIT
K093072 · Dentalez, Inc. · Dec 2009
ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP
K093084 · Rolence Ent., Inc. · Dec 2009
K093341 · CENTURY MODEL 105C
Download PDF FDA Summary Sybron Dental Special…