Cleared Special

CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES (K061175) - FDA 510(k) Clearance

Class I Dental device.

K061175 · Sota Precision Optics, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
26d
Days
Class 1
Risk

K061175 is an FDA 510(k) clearance for the CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Sota Precision Optics, Inc. (Roswell, US). The FDA issued a Cleared decision on May 23, 2006 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sota Precision Optics, Inc. devices

Submission Details

510(k) Number K061175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2006
Decision Date May 23, 2006
Days to Decision 26 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 127d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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
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