Cleared Traditional

K150830 - CompleClear Plastic Orthodontic Bracket and Wire Appliance

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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
387d slower than avg
Panel avg: 128d · 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 Consultant

Blackwell Device Consulting
ANGELA BLACKWELL

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K150830.
Blue Sky Bio Computerized Orthodontic Bracket System
K182338 · Blue Sky Bio · Nov 2018
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
K180718 · Tomy, Inc. · Oct 2018
Carriere Motion Clear Class II
K160720 · Ortho Organizers, Inc. · Nov 2016
Exceed Tx
K150702 · Great Lakes Orthodontics, Ltd. · Mar 2016
COMPOSITE ORTHODONTIC BRACKETS
K140807 · Ortho Specialties · Nov 2014
INSIGNIA DIGICAST
K123118 · Ormco Corp. · Mar 2013
K150830 · CompleClear Plastic Orthodontic Bracket and Wire Appliance
Download PDF FDA Summary Oracrew