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FDA 510(k)

TIN COATED NITI ORTHODONTIC ARCH WIRES

K-Number: K885086 · 1989-01-10

ApplicantFlexmedics
Decision Date1989-01-10
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TIN COATED NITI ORTHODONTIC ARCH WIRES is the device name listed in this FDA 510(k) record. The listed applicant is Flexmedics. It received FDA 510(k) clearance on 1989-01-10 under 510(k) number K885086. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIN COATED NITI ORTHODONTIC ARCH WIRES?

TIN COATED NITI ORTHODONTIC ARCH WIRES is a medical device that received FDA 510(k) clearance on 1989-01-10. The listed applicant is Flexmedics. The 510(k) number is K885086.

When did TIN COATED NITI ORTHODONTIC ARCH WIRES receive FDA 510(k) clearance?

TIN COATED NITI ORTHODONTIC ARCH WIRES received FDA 510(k) clearance on 1989-01-10, under 510(k) number K885086.

Who is the listed applicant for TIN COATED NITI ORTHODONTIC ARCH WIRES?

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

What is the FDA product code for TIN COATED NITI ORTHODONTIC ARCH WIRES?

The FDA product code for TIN COATED NITI ORTHODONTIC ARCH WIRES is EJF.

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Other records listing Flexmedics 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.

K990765FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NOK964955FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS ENCAP+/GUIDEWIRE(REGULAR SHAFT/STIFF SHAFT) NO MARKINGK952430FINESSE GUIDEWIRE CORONARYK943390FLEXFINDER GUIDEWIREK942074FLEXFINDER GUIDEWIREK934265FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE

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Related Devices (Code: EJF)

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.

K994357BITEM LOCK, MODELS SW006, SW012Thermoelastic Technologies, Inc.K932825MICROARCH GOLD BRACKETGac Intl., Inc.K933501ALASTIKUnitek Corp.K923372MEMORY WIREAlthan, Inc.K933080ORTHOTECH DURA-GOLD BARCKETSOrthotechK935139FASCINATION CERAMIC BRACKETDentauraum, 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.

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