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FDA 510(k)

ORTHODONITC METAL REINFORCED PLASTIC BRACKET

K-Number: K942826 · 1994-12-14

ApplicantGac Intl., Inc.
Decision Date1994-12-14
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONITC METAL REINFORCED PLASTIC BRACKET 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 1994-12-14 under 510(k) number K942826. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONITC METAL REINFORCED PLASTIC BRACKET?

ORTHODONITC METAL REINFORCED PLASTIC BRACKET is a medical device that received FDA 510(k) clearance on 1994-12-14. The listed applicant is Gac Intl., Inc.. The 510(k) number is K942826.

When did ORTHODONITC METAL REINFORCED PLASTIC BRACKET receive FDA 510(k) clearance?

ORTHODONITC METAL REINFORCED PLASTIC BRACKET received FDA 510(k) clearance on 1994-12-14, under 510(k) number K942826.

Who is the listed applicant for ORTHODONITC METAL REINFORCED PLASTIC BRACKET?

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 ORTHODONITC METAL REINFORCED PLASTIC BRACKET?

The FDA product code for ORTHODONITC METAL REINFORCED PLASTIC BRACKET is DYW.

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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.

K981036SMARTBONDK933542MESIAL LOOP BARK932825MICROARCH GOLD BRACKETK932319ORTHODONTIC ELASTOMERK932025ION-IMPLANTED NEO SENTALLOYK920905BIOFORCE WIRE

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Related Devices (Code: DYW)

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.

K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.K251196Composite Orthodontic Brackets and ButtonsEc Certification Service GmbHK201940Braces on Demand BracketBraces on Demand, Inc.K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky BioK180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc.K160720Carriere Motion Clear Class IIOrtho Organizers, 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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