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FDA 510(k)

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System

K-Number: K180404 · 2018-03-16

Applicant3M Healthcare
Decision Date2018-03-16
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System is a medical device manufactured by 3M Healthcare. It received FDA 510(k) clearance on 2018-03-16 under approval number K180404. 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 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System?

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System is a medical device that received FDA 510(k) clearance on 2018-03-16. It is manufactured by 3M Healthcare. The 510(k) number is K180404.

When was 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System approved by the FDA?

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System received FDA 510(k) clearance on 2018-03-16, under approval number K180404.

What company makes 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System?

3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System is manufactured by 3M Healthcare.

What is the FDA product code for 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System?

The FDA product code for 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System is NJM.

Related Clinical Trials

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Related PubMed Literature

PMID: 41747807 Silicone-oil migration in prefilled syringes induces smoke-like particulates in ultra-high viscosity formulations. Journal of pharmaceutical sciences (2026) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by 3M Healthcare

K153571Cavilon Advanced High Endurance Skin Protectant K1711163M™ VFlex™ Health Care Particulate Respirator and Surgical Mask , Models 1804/1804S K1808743M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield K1913553M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

Related Devices (Code: NJM)

K160957CDB Self Ligating Bracket 8FCdb Corporation K160615ORTHODONTIC CERAMIC BRACKETS 1.1Tomy, Inc. 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

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.

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