BEUDAMED
    Product Code: PNN FDA class 2 21 CFR 872.5470

    Orthodontic Software

    Dental

    The Orthodontic Software (product code PNN) is a Class 2 dental prescription device used for the diagnosis and treatment planning of orthodontic patients and conditions, and may include orthodontic output devices used for the treatment of orthodontics, regulated under 872.5470. It requires 510(k) clearance and falls within the dental medical specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    34
    FEI Numbers
    41
    Registration Numbers
    41
    Unique Applicants
    27
    Years Active
    10

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    Basic Information

    Product Code
    PNN
    Device Class
    FDA class 2
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

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

    Definition

    The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 34 510(k) clearances via K numbers.

    K Number Device Name
    K260419 LingOral Dental Design System
    K253565 SureSmile Software
    K252507 SmileInspector
    K253343 Celebrace Software
    K250198 Laon Ortho
    K241153 Progressive Orthodontics App
    K233625 RAYDENT SW
    K232564 Align Studio
    K233616 Clevaligner Software (V1.0.0)
    K232549 NemoCast
    K232429 Titan Dental Design
    K223518 iOrtho
    K212173 HDH Treatment Planning System
    K212770 Vision
    K213916 ArchForm Orthodontic Software System
    K212828 BRIUS Planner Software
    K203442 Inbrace Orthodontic System
    K201036 PlaniMax Orthodontic Software
    K192847 AUTOLIGN
    K200772 ULab Systems uDesign Software
    K193003 NemoCast
    K192701 DIBS (Digital Indirect Bonding System)
    K191720 BRUIS Software Suite
    K193390 CS Model+
    K191911 3Shape Splint Design
    K183695 OrthoAnalysis Software
    K181112 Orchestrate 3D
    K180941 Ortho System
    K171634 Ortho System
    K171122 CEREC Ortho Software
    K171295 ULab Systems Treatment Planning Software
    K163677 Ortho System
    K162850 GuideMia Ortho+
    K152086 3Shape Ortho System

    FEI Numbers

    This FDA classification entry is associated with 41 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 41 registration numbers. Click on an entry to view related FDA registrations.