Cleared Traditional

K101676 - CLEARARCH

K101676 is an FDA 510(k) clearance for CLEARARCH, manufactured by Ormco Corp.. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K101676 · Ormco Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
90d
Days
Class 2
Risk

K101676 is an FDA 510(k) clearance for the CLEARARCH. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Ormco Corp. (Orange, US). The FDA issued a Cleared decision on September 13, 2010 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 872.5470 - 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 - K101676

510(k) Number K101676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2010
Decision Date September 13, 2010
Days to Decision 90 days
Submission Type Traditional
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
38d faster than avg
Panel avg: 128d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYW Device Classification - Class 2, Special Controls

Product Code DYW Bracket, Plastic, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DYW Bracket, Plastic, Orthodontic

All 39
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K101676.
INSIGNIA WITH ITERO
K123416 · Ormco Corp. · Mar 2013
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ORTHOCAD IQ
K082207 · Cadent, Inc. · Oct 2009
ELATION MB METAL REINFORCED PLASTIC BRACKET
K092030 · Dentsply Interntional · Jul 2009
BIOMERS TRANSLUCENT ORTHODONTIC WIRE
K081143 · Biomers Product, LLC · May 2008
K101676 · CLEARARCH
Download PDF FDA Summary Ormco Corp.