Cleared Abbreviated

K032341 - INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310

K032341 is an FDA 510(k) clearance for INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, manufactured by Sota Precision Optics, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Abbreviated 510(k) pathway after a 27-day FDA review.

K032341 · Sota Precision Optics, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K032341

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 128d · This submission: 27d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Intertek Testing Services
DONALD J SHERRATT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EIA Unit, Operative Dental

All 256
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K032341 · INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I310
Download PDF FDA Summary Sota Precision Optics…