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FDA 510(k)

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

K-Number: K180718 · 2018-10-30

ApplicantTomy, Inc.
Decision Date2018-10-30
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Tomy, Inc.. It received FDA 510(k) clearance on 2018-10-30 under 510(k) number K180718. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Tomy, Inc.. The 510(k) number is K180718.

When did ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES receive FDA 510(k) clearance?

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES received FDA 510(k) clearance on 2018-10-30, under 510(k) number K180718.

Who is the listed applicant for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

The FDA 510(k) record lists Tomy, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

The FDA product code for ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES is DYW.

Other records listing Tomy, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160615ORTHODONTIC CERAMIC BRACKETS 1.1

Related Devices (Code: DYW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.K251196Composite Orthodontic Brackets and ButtonsEc Certification Service GmbHK201940Braces on Demand BracketBraces on Demand, Inc.K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky BioK160720Carriere Motion Clear Class IIOrtho Organizers, Inc.K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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