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 CERAMIC BRACKETS 1.1

K-Number: K160615 · 2016-08-26

ApplicantTomy, Inc.
Decision Date2016-08-26
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC CERAMIC BRACKETS 1.1 is a medical device manufactured by Tomy, Inc.. It received FDA 510(k) clearance on 2016-08-26 under approval number K160615. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONTIC CERAMIC BRACKETS 1.1?

ORTHODONTIC CERAMIC BRACKETS 1.1 is a medical device that received FDA 510(k) clearance on 2016-08-26. It is manufactured by Tomy, Inc.. The 510(k) number is K160615.

When was ORTHODONTIC CERAMIC BRACKETS 1.1 approved by the FDA?

ORTHODONTIC CERAMIC BRACKETS 1.1 received FDA 510(k) clearance on 2016-08-26, under approval number K160615.

What company makes ORTHODONTIC CERAMIC BRACKETS 1.1?

ORTHODONTIC CERAMIC BRACKETS 1.1 is manufactured by Tomy, Inc..

What is the FDA product code for ORTHODONTIC CERAMIC BRACKETS 1.1?

The FDA product code for ORTHODONTIC CERAMIC BRACKETS 1.1 is NJM.

Related Clinical Trials

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 NCT07517601 Erbium-doped Yttrium Aluminum Garnet (Er:YAG) Laser vs Conventional Ceramic Bracket Debonding: A Split-Mouth Clinical Trial ACTIVE_NOT_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.

K180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

Related Devices (Code: NJM)

K160957CDB Self Ligating Bracket 8FCdb Corporation K152167BIJOU Orthodontic Ceramic BracketWorld Bio Tech Co., Ltd. K171844Inspire ICE aka Inspire ICE Clear BracketsOrmco Corporation K163467C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. K163117Alpha PureKoroad America K181271Signature Orthodontic SystemSignature Orthodontics

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.

↑