Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Tomy, Inc.. It received FDA 510(k) clearance on 2018-10-30 under approval 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. It is manufactured by Tomy, Inc.. The 510(k) number is K180718.

When was ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES approved by the FDA?

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

What company makes ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES?

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES is manufactured by Tomy, Inc..

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

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

Related Clinical Trials

NCT07610603 Cleaning Methods for Clear Aligners COMPLETED NCT07318623 Comparative Outcomes of Damon Ultima vs Pitts 21 Pro Bracket Systems NOT_YET_RECRUITING NCT07355400 Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances RECRUITING NCT07511296 Orthognathic Surgery With Clear Aligners vs Conventional Brackets COMPLETED NCT07503314 Comparison of Alignment Efficiency, Arch Dimensional Changes, and Passive Extraction Space Closure Between Self-Ligating and Conventional Brackets COMPLETED

Other Devices by Tomy, Inc.

K160615ORTHODONTIC CERAMIC BRACKETS 1.1

Related Devices (Code: DYW)

K160720Carriere Motion Clear Class IIOrtho Organizers, Inc. K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew K150702Exceed TxGreat Lakes Orthodontics, Ltd. K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky Bio K201940Braces on Demand BracketBraces on Demand, Inc. K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.

Official Source

View on FDA Database →

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

↑