Cleared Abbreviated

K092917 - STERN'S S250 NORDAM

K092917 is an FDA 510(k) clearance for STERN'S S250 NORDAM, manufactured by Cefla S.C.. The device is a Class 1 Dental device with product code EIA cleared through the Abbreviated 510(k) pathway after a 275-day FDA review.

K092917 · Cefla S.C. · Dental device
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Jun 2010
Decision
275d
Days
Class 1
Risk

K092917 is an FDA 510(k) clearance for the STERN'S S250 NORDAM. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Cefla S.C. (Ormond Beach, US). The FDA issued a Cleared decision on June 24, 2010 after a review of 275 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K092917

510(k) Number K092917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2009
Decision Date June 24, 2010
Days to Decision 275 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 128d · This submission: 275d
Pathway characteristics
Standards-based clearance path.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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 - EIA Unit, Operative Dental

All 284
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K092917.
YOBOSHI DENTAL UNIT
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A-DEC 200 DENTAL SYSTEM
K102234 · A-Dec, Inc. · Nov 2010
DENTACENTER/EXPEDITION, MODEL SAF-430
K100212 · Safari Dental, Inc. · Oct 2010
MODEL GDCH-2000
K092851 · Global Dental Direct, Inc. · Sep 2009
KODAK 1500 INTRAORAL CAMERA
K091186 · Carestream Health, Inc. · Aug 2009
VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
K090079 · Progeny, Inc. · May 2009
K092917 · STERN'S S250 NORDAM
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