Cleared Traditional

K180718 - ORTHODONTIC PLASTIC BRACKETS AND ACCESS...

K180718 is an FDA 510(k) clearance for ORTHODONTIC PLASTIC BRACKETS AND ACCESS..., manufactured by Tomy, Inc.. The device is a Class 2 Dental device with product code DYW cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K180718 · Tomy, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Oct 2018
Decision
225d
Days
Class 2
Risk

K180718 is an FDA 510(k) clearance for the ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES. Classified as Bracket, Plastic, Orthodontic (product code DYW), Class II - Special Controls.

Submitted by Tomy, Inc. (Midori-Cho, Fuchu City, JP). The FDA issued a Cleared decision on October 30, 2018 after a review of 225 days - an extended review cycle.

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.

View all Tomy, Inc. devices

FDA 510(k) Submission Details - K180718

510(k) Number K180718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2018
Decision Date October 30, 2018
Days to Decision 225 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
98d slower than avg
Panel avg: 127d · This submission: 225d
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

Regulatory & Quality Solutions, Inc.
Ruthanne Vendy

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 22
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