Cleared Special

K061175 - CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES

K061175 is an FDA 510(k) clearance for CLARIS I310D INTRAORAL CAMERA SYSTEM & ..., manufactured by Sota Precision Optics, Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Special 510(k) pathway after a 26-day FDA review.

K061175 · Sota Precision Optics, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K061175

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 128d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 256
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K061175.
C-U2
K062897 · Cefla S.C.R.L. · Dec 2006
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES
K063302 · Shanghai Dental Instrument Factory · Nov 2006
COMPACT PLUS - EXTREME - PERFECT PLUS
K052574 · J.O. Suarez & Cia, Ltda · Jul 2006
ABSOLUTE AMERICA
K050571 · Eurodent S.P.A. · Nov 2005
F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT
K052470 · Shanghai Fimet Medical Instrument Co., Ltd. · Nov 2005
A-DEC SELF-CONTAINED WATER SYSTEM
K051657 · A-Dec, Inc. · Aug 2005
K061175 · CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES
Download PDF FDA Summary Sota Precision Optics…