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

    BruxZir® NOW

    K Number: K252446 · Decision Sep 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    481
    Applicant Total
    57
    Review Days
    30

    Basic Information

    Device Name
    BruxZir® NOW
    K Number
    K252446
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.6660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prismatik Dentalcraft, Inc.
    Date Received
    August 4, 2025
    Decision Date
    September 3, 2025
    Product Code
    EIH
    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
    EIH Powder, Porcelain

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EIH), ordered by most recent decision date.

    Rosetta SM, Rosetta SP

    FDA 510(k)
    FDA Class 2 ·Dental

    DCMhotbond zircon

    FDA 510(k)
    FDA Class 2 ·Dental

    Eternal Art Porcelain Powders

    FDA 510(k)
    FDA Class 2 ·Dental

    Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

    FDA 510(k)
    FDA Class 2 ·Dental

    IPS e.max Zirconia

    FDA 510(k)
    FDA Class 2 ·Dental

    BruxZir® Shaded 16 PLUS

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Prismatik Dentalcraft, Inc.

    K Number Device Name
    K254283 BruxZir® Shaded 16 PLUS
    K252582 Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems
    K250302 Flexible Partial Resin
    K242564 Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)
    K250223 BruxZir® Esthetic NOW
    K241493 Glidewell™ 3DP Denture Base Resin
    K240240 Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems
    K231940 BruxZir® NOW SRC
    K240882 BruxZir® Esthetic
    K240574 BruxZir® Radiant
    Search all 57 clearances from Prismatik Dentalcraft, Inc. →