Cleared Abbreviated

INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310 (K032341) - FDA 510(k) Clearance

Class I Dental device.

K032341 · Sota Precision Optics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
27d
Days
Class 1
Risk

K032341 is an FDA 510(k) clearance for the INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Sota Precision Optics, Inc. (Alpharetta, US). The FDA issued a Cleared decision on August 25, 2003 after a review of 27 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 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.

View all Sota Precision Optics, Inc. devices

Submission Details

510(k) Number K032341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2003
Decision Date August 25, 2003
Days to Decision 27 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 127d · This submission: 27d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 K032341.
Forest Dental Unit
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KSEA ENDOSCOPES FOR DENTAL PROCEDURES
K982658 · KARL STORZ Endoscopy-America, Inc. · Oct 1998
MOBILE UNITS, I,II,III,IV
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