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FDA 510(k)

CERAMIC ORTHODONIT APPLIANCE

K-Number: K852179 · 1985-08-20

ApplicantGac Intl., Inc.
Decision Date1985-08-20
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAMIC ORTHODONIT APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Gac Intl., Inc.. It received FDA 510(k) clearance on 1985-08-20 under 510(k) number K852179. 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 CERAMIC ORTHODONIT APPLIANCE?

CERAMIC ORTHODONIT APPLIANCE is a medical device that received FDA 510(k) clearance on 1985-08-20. The listed applicant is Gac Intl., Inc.. The 510(k) number is K852179.

When did CERAMIC ORTHODONIT APPLIANCE receive FDA 510(k) clearance?

CERAMIC ORTHODONIT APPLIANCE received FDA 510(k) clearance on 1985-08-20, under 510(k) number K852179.

Who is the listed applicant for CERAMIC ORTHODONIT APPLIANCE?

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

What is the FDA product code for CERAMIC ORTHODONIT APPLIANCE?

The FDA product code for CERAMIC ORTHODONIT APPLIANCE is EJF.

Related Clinical Trials

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Other records listing Gac Intl., Inc. 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.

K981036SMARTBONDK942826ORTHODONITC METAL REINFORCED PLASTIC BRACKETK933542MESIAL LOOP BARK932825MICROARCH GOLD BRACKETK932319ORTHODONTIC ELASTOMERK932025ION-IMPLANTED NEO SENTALLOY

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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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