Cleared Traditional

K092933 - SAF (SELF ADJUSTING FILE)

K092933 is an FDA 510(k) clearance for SAF (SELF ADJUSTING FILE), manufactured by Redent-Nova , Ltd.. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K092933 · Redent-Nova , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
113d
Days
Class 1
Risk

K092933 is an FDA 510(k) clearance for the SAF (SELF ADJUSTING FILE). Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Redent-Nova , Ltd. (Washington, D.C., US). The FDA issued a Cleared decision on January 14, 2010 after a review of 113 days - within the typical 510(k) review window.

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 - K092933

510(k) Number K092933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2009
Decision Date January 14, 2010
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 128d · This submission: 113d
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 237
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K092933.
SYLE SMARTIP
K100833 · Osspray, Ltd. · Jun 2010
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K093341 · Sybron Dental Specialties, Inc. · Apr 2010
STARCARE HANDPIECE MAINTENANCE UNIT
K093072 · Dentalez, Inc. · Dec 2009
ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP
K093084 · Rolence Ent., Inc. · Dec 2009
EMS AIR-FLOW HANDY PERIO
K092289 · E.M.S Electro Medical Systems S.A · Oct 2009
K092933 · SAF (SELF ADJUSTING FILE)
Download PDF FDA Summary Redent-Nova , Ltd.