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FDA 510(k)

COATED ORTHODONTIC DEVICES

K-Number: K931631 · 1993-07-28

ApplicantWonder Wire
Decision Date1993-07-28
Product CodeDZC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COATED ORTHODONTIC DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Wonder Wire. It received FDA 510(k) clearance on 1993-07-28 under 510(k) number K931631. The device is classified under product code DZC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COATED ORTHODONTIC DEVICES?

COATED ORTHODONTIC DEVICES is a medical device that received FDA 510(k) clearance on 1993-07-28. The listed applicant is Wonder Wire. The 510(k) number is K931631.

When did COATED ORTHODONTIC DEVICES receive FDA 510(k) clearance?

COATED ORTHODONTIC DEVICES received FDA 510(k) clearance on 1993-07-28, under 510(k) number K931631.

Who is the listed applicant for COATED ORTHODONTIC DEVICES?

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

What is the FDA product code for COATED ORTHODONTIC DEVICES?

The FDA product code for COATED ORTHODONTIC DEVICES is DZC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Wonder Wire 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.

K872622ORTHODONTIC ARCH

Related Devices (Code: DZC)

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.

K112640HYPERELASTIC WIREOrmco Corp.K943334HAWLEY RETAINER ORTHODONTIC APPLICANCE KITJay H. GellerK935638NITINOL, NITIHighland MetalsK935140DENTAURUM STEEL LIGATURE WIRESDentauraum, Inc.K935142DENTAURUM WIRESDentauraum, Inc.K934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIREFlexmedics

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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