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Gac Intl., Inc.

United StatesFDA applicant, unverified

Devices
13

What Gac Intl., Inc. makes

Gac Intl., Inc. manufactures orthodontic appliances and components, including stainless steel brackets, ceramic appliances, elastomers, and reinforced plastic brackets. Their portfolio also includes specialized wires like Sentinol and Bioforce, as well as devices for thumb-sucking control and orthodontic arch support, such as the mesial loop bar and face bow with inner wire. The company produces implantable materials like ion-implanted Neo Sentalloy and bonding systems, including SmartBond, for dental applications.

The company’s devices are regulated under FDA Class I and Class II classifications, with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry. Gac Intl., Inc. is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

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  • Ion-Implanted Neo Sentalloy Ref K932025

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gac Thumb-Sucking Control Appliance Ref K920850

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Orthodontic Stainless Steel Bracket Ref K923029

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Orthodontic Elastomer Ref K932319

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Smartbond Ref K981036

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • New Base For Orthodontic Appliances Ref K771774

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sentinol -Orthodontic Arch Wire Ref K851055

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Bioforce Wire Ref K920905

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ceramic Orthodonit Appliance Ref K852179

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Orthodonitc Metal Reinforced Plastic Bracket Ref K942826

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Orthodontic Face Bow W/ Inner Wire Ref K920784

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mesial Loop Bar Ref K933542

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Microarch Gold Bracket Ref K932825

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-13 of 13

Frequently asked questions

How many devices does Gac Intl., Inc. have in the registry?

The registry currently lists 13 devices for Gac Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gac Intl., Inc.'s devices?

Among its 13 most recently registered devices, Gac Intl., Inc. has devices listed in FDA 510(k) (13 devices).

What risk classes do Gac Intl., Inc.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Gac Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Gac Intl., Inc. in the registry?

The most recently registered devices listed for Gac Intl., Inc. include ION-IMPLANTED NEO SENTALLOY, GAC THUMB-SUCKING CONTROL APPLIANCE, ORTHODONTIC STAINLESS STEEL BRACKET and ORTHODONTIC ELASTOMER.

Generated automatically from registry data and not verified by a human reviewer.