Cleared Traditional

INTRAORAL LENS OPTION TO SPECTROSHADE (K012744) - FDA 510(k) Clearance

Class I Dental device.

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.

View all Mht Optic Research AG devices

Submission Details

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
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 127d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 25
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K012744.
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KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
MOBILE UNITS, I,II,III,IV
K790112 · Dentsply Intl. · Feb 1979