BEUDAMED
    Product Code: NVK FDA class 2 21 CFR 878.4810

    Laser, Dental, Soft Tissue

    General, Plastic Surgery

    The Dental Soft Tissue Laser is a surgical laser device intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. It enables precise, minimally invasive soft tissue procedures in the oral cavity with reduced bleeding compared to conventional surgical instruments. It is an FDA Class 2 device regulated under 21 CFR 878.4810 in the General and Plastic Surgery specialty, reviewed by the Dental panel, with product code NVK, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not carry life-sustaining support designation.

    View on FDA
    510(k)s
    17
    FEI Numbers
    19
    Registration Numbers
    19
    Unique Applicants
    13
    Years Active
    21

    Research product code NVK in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    NVK
    Device Class
    FDA class 2
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

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

    Definition

    Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 17 510(k) clearances via K numbers.

    K Number Device Name
    K253309 SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)
    K260765 Gemini NOVA 810+980 Soft Tissue Laser
    K250731 MateLaser Medical Diode Laser Systems (ML-DLS-30)
    K243764 Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
    K230047 Medical Diode Laser Systems
    K232885 Dawn Diode Laser System
    K232222 Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)
    K221761 Solea
    K211150 Dental diode laser, SOGA Laser, ILaser II
    K214008 Dental diode laser
    K213658 DEKA SMARTPERIO
    K210367 D-Laser Blue, D-Laser 16
    K213428 EdgePro
    K210350 Gemini 2 810+980 Soft Tissue Laser
    K203396 DEKA SMARTPERIO
    K201387 Ultrafast, Ultrafast Plus, Ultrafast Lite
    K030146 KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+

    FEI Numbers

    This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.