Cleared Traditional

K020206 - INTRAORAL CAMERA ME-15

K020206 is an FDA 510(k) clearance for INTRAORAL CAMERA ME-15, manufactured by Dent Corp. Research & Development. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K020206 · Dent Corp. Research & Development · Dental device
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Apr 2002
Decision
79d
Days
Class 1
Risk

K020206 is an FDA 510(k) clearance for the INTRAORAL CAMERA ME-15. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Dent Corp. Research & Development (White Plains, US). The FDA issued a Cleared decision on April 11, 2002 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K020206

510(k) Number K020206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2002
Decision Date April 11, 2002
Days to Decision 79 days
Submission Type Traditional
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
49d faster than avg
Panel avg: 128d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

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 268
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K020206.
VERACAM
K021083 · Lumalite, Inc. · Aug 2002
BOYD DELIVERY UNIT
K020833 · Boyd Industries, Inc. · Aug 2002
ORACAM
K020957 · Video Dental Concepts, Inc. · Jun 2002
IDENT-A100 INTRAORAL VIDEO CAMERA
K013690 · Confident Technology, Inc. · Jan 2002
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K012744 · Mht Optic Research AG · Jan 2002
SOPRO595 INTRA ORAL CAMERA
K012505 · Sopro · Oct 2001
K020206 · INTRAORAL CAMERA ME-15
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