Cleared Traditional

K150830 - CompleClear Plastic Orthodontic Bracket...

K150830 is an FDA 510(k) clearance for CompleClear Plastic Orthodontic Bracket..., manufactured by Oracrew. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 515-day FDA review.

K150830 · Oracrew · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
515d
Days
Class 2
Risk

K150830 is an FDA 510(k) clearance for the CompleClear Plastic Orthodontic Bracket and Wire Appliance. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Oracrew (Las Vegas, US). The FDA issued a Cleared decision on August 26, 2016 after a review of 515 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Oracrew devices

FDA 510(k) Submission Details - K150830

510(k) Number K150830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2015
Decision Date August 26, 2016
Days to Decision 515 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
388d slower than avg
Panel avg: 127d · This submission: 515d
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 24
Devices cleared under the same product code (DYW) and FDA review panel - the closest regulatory comparables to K150830.
Braces on Demand Bracket
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Blue Sky Bio Computerized Orthodontic Bracket System
K182338 · Blue Sky Bio · Nov 2018
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K180718 · Tomy, Inc. · Oct 2018
INSIGNIA DIGICAST
K123118 · Ormco Corp. · Mar 2013
INSIGNIA WITH ITERO
K123416 · Ormco Corp. · Mar 2013
INSIGNIA
K121524 · Ormco Corp. · Aug 2012