BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Rest Assure System

    K Number: K233497 · Decision Oct 3, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    11
    Review Days
    338

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    Basic Information

    Device Name
    Rest Assure System
    K Number
    K233497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Somnomed, Inc.
    Date Received
    October 31, 2023
    Decision Date
    October 3, 2024
    Product Code
    PLC
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PLC Sleep Appliances With Patient Monitoring

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    Other Clearances by Somnomed, Inc.

    K Number Device Name
    K261366 Virtus
    K183443 SomnoDent Avant
    K162306 SomnoDent ALPHA
    K150369 SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder
    K140278 SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
    K130558 SOMNODENT HERBST; CLASSIC, FLEX
    K121340 SOMNODENT G2
    K102909 SOMNOBRUX SPLINTS
    K102521 PANTINO PRO POSITINER
    K073004 SOMNOMED BFLEX
    Search all 11 clearances from Somnomed, Inc. →