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FDA 510(k)

FILAFEX TM, ESTHETIC ORTHODONTIC WIRE

K-Number: K843171 · 1984-12-03

ApplicantBerkley and Co.
Decision Date1984-12-03
Product CodeDZC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FILAFEX TM, ESTHETIC ORTHODONTIC WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Berkley and Co.. It received FDA 510(k) clearance on 1984-12-03 under 510(k) number K843171. 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 FILAFEX TM, ESTHETIC ORTHODONTIC WIRE?

FILAFEX TM, ESTHETIC ORTHODONTIC WIRE is a medical device that received FDA 510(k) clearance on 1984-12-03. The listed applicant is Berkley and Co.. The 510(k) number is K843171.

When did FILAFEX TM, ESTHETIC ORTHODONTIC WIRE receive FDA 510(k) clearance?

FILAFEX TM, ESTHETIC ORTHODONTIC WIRE received FDA 510(k) clearance on 1984-12-03, under 510(k) number K843171.

Who is the listed applicant for FILAFEX TM, ESTHETIC ORTHODONTIC WIRE?

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

What is the FDA product code for FILAFEX TM, ESTHETIC ORTHODONTIC WIRE?

The FDA product code for FILAFEX TM, ESTHETIC ORTHODONTIC WIRE 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 Berkley and Co. 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.

K854579HYPODERMIC NEEDLE AND STYLETK833788FILAFEX ESTHETIC ORTHODINIC WIRE

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

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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