Cleared Traditional

K063646 - OPTI

K063646 is an FDA 510(k) clearance for OPTI, manufactured by Camsight Co., Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K063646 · Camsight Co., Inc. · Dental device
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Mar 2007
Decision
90d
Days
Class 1
Risk

K063646 is an FDA 510(k) clearance for the OPTI. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Camsight Co., Inc. (Los Angeles, US). The FDA issued a Cleared decision on March 7, 2007 after a review of 90 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K063646

510(k) Number K063646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2006
Decision Date March 07, 2007
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 128d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

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 268
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K063646.
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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
K063646 · OPTI
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