BEUDAMED
    Product Code: OAT FDA class 2 21 CFR 872.3640

    Implant, Endosseous, Orthodontic

    Dental

    The Implant, Endosseous, Orthodontic (product code OAT) is a small implant placed in the jawbone to provide a fixed anchorage point for orthodontic appliances, facilitating controlled tooth movement during orthodontic treatment, after which the implant is removed. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 872.3640 within the Dental specialty. This device carries an implant flag due to its temporary osseous placement.

    View on FDA
    510(k)s
    52
    FEI Numbers
    54
    Registration Numbers
    54
    Unique Applicants
    43
    Years Active
    28

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    Basic Information

    Product Code
    OAT
    Device Class
    FDA class 2
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

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

    Definition

    It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 52 510(k) clearances via K numbers.

    K Number Device Name
    K260268 OrthoEasy Pal; OrthoEasy Pal Long Neck
    K242944 Leone Orthodontic Implant TAD (Temporary Anchorage Device)
    K231502 Mini Screws
    K231913 T-FIT
    K222245 ACR Screw System
    K202163 Mico One Orthodontic Screw
    K202691 Ortholock Anchorage Devices
    K210559 ATOZ Mini-Screw
    K211992 Ortho MI System
    K202790 Syntec Orthodontic Mini Screw Extended System
    K202278 OBS Anchorage Screw, Biokey Anchorage Screw
    K201919 Blue Sky Bio TAD
    K191041 Orthodontic Fixation Screw [Smart Anchor Miniscrew]
    K190871 Bio-TackS Orthodontic Mini Implant
    K182929 BIO-RAY A-1 Anchor Screw System
    K181142 Absoanchor Microimplant
    K173623 Anchor plate
    K161335 Dual Top Screw System
    K161197 Orthodontic Screw
    K152297 OBS Anchorage Screw
    K142001 SYNTEC WETALI ORTHODONTIC MINI SCREWS
    K130476 ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE
    K122069 STORM MINI SCREW
    K120861 FIN-S MICROIMPLANT
    K113650 ORTHOFIX SCREW
    K110392 PSM LOMAS / BENEFIT SCREWS
    K111809 SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
    K110275 ORTHO EASY PIN
    K103105 ORTHODONTIC SCREW
    K102769 NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
    K093299 SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
    K100633 INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016
    K091390 HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2
    K090476 SYNTEC ORTHODONTIC MINI SCREW
    K081393 ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW
    K071490 LEONE ORTHODONTIC MINI IMPLANT
    K073461 ORTHO ANCHOR SCREWS
    K072086 INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM
    K063495 C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS
    K063770 ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM
    K063473 SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
    K063149 ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM)
    K063386 LORENZ ORTHODONTIC ANCHORAGE SYSTEM
    K062733 TOMAS PIN SD 6, 8, AND 10 MM
    K062732 TOMAS PIN 6 MM
    K061397 ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
    K061230 VECTORS TEMPORARY ANCHORAGE SYSTEM
    K061266 ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
    K060062 STRAUMANN ORTHOSYSTEM
    K042965 TOMAS PIN
    K040469 THE STRAUMANN ORTHO IMPLANT SYSTEM
    K982509 ORTHO IMPLANT AND ACCESSORIES

    FEI Numbers

    This FDA classification entry is associated with 54 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 54 registration numbers. Click on an entry to view related FDA registrations.