Cleared Traditional

K012744 - INTRAORAL LENS OPTION TO SPECTROSHADE

K012744 is an FDA 510(k) clearance for INTRAORAL LENS OPTION TO SPECTROSHADE, manufactured by Mht Optic Research AG. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K012744 · Mht Optic Research AG · Dental device
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Jan 2002
Decision
160d
Days
Class 1
Risk

K012744 is an FDA 510(k) clearance for the INTRAORAL LENS OPTION TO SPECTROSHADE. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Mht Optic Research AG (Niederhasli, CH). The FDA issued a Cleared decision on January 23, 2002 after a review of 160 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 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 - K012744

510(k) Number K012744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2001
Decision Date January 23, 2002
Days to Decision 160 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
32d slower than avg
Panel avg: 128d · This submission: 160d
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 282
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K012744.
ORACAM
K020957 · Video Dental Concepts, Inc. · Jun 2002
INTRAORAL CAMERA ME-15
K020206 · Dent Corp. Research & Development · Apr 2002
IDENT-A100 INTRAORAL VIDEO CAMERA
K013690 · Confident Technology, Inc. · Jan 2002
SOPRO595 INTRA ORAL CAMERA
K012505 · Sopro · Oct 2001
GULLIVER AND CLASSE A
K012213 · American Dental Technologies, Inc. · Aug 2001
PORTABELL, MODEL 4200
K011222 · Bell Dental Products, LLC · Jun 2001
K012744 · INTRAORAL LENS OPTION TO SPECTROSHADE
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