BEUDAMED
    Product Code: ORY FDA class 2 21 CFR 872.5570

    Tongue Suspension System

    Dental

    The Tongue Suspension System (product code ORY) is a dental implant device used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring. As an FDA Class 2 device under regulation 872.5570, it requires 510(k) premarket clearance and falls within the Dental specialty. The device is flagged as an implant due to the bone screw component, though it is not life-sustaining.

    View on FDA
    510(k)s
    10
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    11

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    Basic Information

    Product Code
    ORY
    Device Class
    FDA class 2
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 10 510(k) clearances via K numbers.

    K Number Device Name
    K213159 Encore System
    K201238 Encore System
    K183310 Encore System
    K133680 ENCORE SYSTEM
    K121440 ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT
    K121814 ENCORE TONGUE SUSPENSION SYSTEM
    K111179 ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN
    K110127 PRELUDE III TONGUE SUSPENSION SYSTEM
    K103179 PRELUDE II TOUNGE SUSPENSION SYSTEM
    K101060 SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.