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Great Lakes Orthodontics, Ltd.

Country not established

Devices
13

What Great Lakes Orthodontics, Ltd. makes

Great Lakes Orthodontics, Ltd. manufactures orthodontic and dental appliances, including removable aligners (e.g., Smart Moves Complete), orthodontic masks (e.g., Keles Facemask, Adaptable Class III Mask), and dental adhesives (e.g., Great Lakes Paste Solder, Metacryl). The company also produces dental reline materials (e.g., Soft Denture Reline Material Elastoline) and oral appliances for sleep-related breathing disorders (e.g., SNORE-NO-MORE, ORAL SAFE). Additional products include orthodontic wires (e.g., Variflex) and treatment systems (e.g., Exceed Tx).

The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry. Great Lakes Orthodontics, Ltd. is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue13

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  • Snore-No-More Ref K922818

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

  • Oral Safe Ref K840805

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

  • Oral Safe Ref K832359

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

  • Variflex Ref K033632

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

  • Exceed Tx Ref K150702

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

  • Smart Moves Complete Ref K172765

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

  • Steady Resin Ref K870908

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

  • Keles Facemask Ref K041718

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

  • Soft Denture Reline Material Elastoline Ref K925275

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

  • Metacryl Ref K040881

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

  • Great Lakes Paste Solder Ref K832425

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

  • Adaptable Class Iii Mask Ref K861424

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

  • Biocryl X Ref K083479

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

Rows 1-13 of 13

Frequently asked questions

How many devices does Great Lakes Orthodontics, Ltd. have in the registry?

The registry currently lists 13 devices for Great Lakes Orthodontics, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Great Lakes Orthodontics, Ltd.'s devices?

Among its 13 most recently registered devices, Great Lakes Orthodontics, Ltd. has devices listed in FDA 510(k) (13 devices).

What risk classes do Great Lakes Orthodontics, Ltd.'s devices fall under?

Among its 13 most recently registered devices, the classes recorded for Great Lakes Orthodontics, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Great Lakes Orthodontics, Ltd. in the registry?

The most recently registered devices listed for Great Lakes Orthodontics, Ltd. include SNORE-NO-MORE, ORAL SAFE, VARIFLEX and Exceed Tx.

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