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FDA 510(k)

NEW BASE FOR ORTHODONTIC APPLIANCES

K-Number: K771774 · 1977-09-30

ApplicantGac Intl., Inc.
Decision Date1977-09-30
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEW BASE FOR ORTHODONTIC APPLIANCES 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 1977-09-30 under 510(k) number K771774. 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 NEW BASE FOR ORTHODONTIC APPLIANCES?

NEW BASE FOR ORTHODONTIC APPLIANCES is a medical device that received FDA 510(k) clearance on 1977-09-30. The listed applicant is Gac Intl., Inc.. The 510(k) number is K771774.

When did NEW BASE FOR ORTHODONTIC APPLIANCES receive FDA 510(k) clearance?

NEW BASE FOR ORTHODONTIC APPLIANCES received FDA 510(k) clearance on 1977-09-30, under 510(k) number K771774.

Who is the listed applicant for NEW BASE FOR ORTHODONTIC APPLIANCES?

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 NEW BASE FOR ORTHODONTIC APPLIANCES?

The FDA product code for NEW BASE FOR ORTHODONTIC APPLIANCES is EJF.

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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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