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FDA 510(k)

ACME COATED ORTHODONTIC ARCHWIRE

K-Number: K895483 · 1990-01-29

ApplicantAcme-Monaco Corp.
Decision Date1990-01-29
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACME COATED ORTHODONTIC ARCHWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Acme-Monaco Corp.. It received FDA 510(k) clearance on 1990-01-29 under 510(k) number K895483. 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 ACME COATED ORTHODONTIC ARCHWIRE?

ACME COATED ORTHODONTIC ARCHWIRE is a medical device that received FDA 510(k) clearance on 1990-01-29. The listed applicant is Acme-Monaco Corp.. The 510(k) number is K895483.

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

ACME COATED ORTHODONTIC ARCHWIRE received FDA 510(k) clearance on 1990-01-29, under 510(k) number K895483.

Who is the listed applicant for ACME COATED ORTHODONTIC ARCHWIRE?

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

What is the FDA product code for ACME COATED ORTHODONTIC ARCHWIRE?

The FDA product code for ACME COATED ORTHODONTIC ARCHWIRE is EJF.

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.

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Other records listing Acme-Monaco Corp. 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.

K113162SLIDEWIRETM(TRADEMARK PENDING)K920884GUIDEWIRES, VARIOUS TYPESK895854ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)K883763ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH

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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