FDA 510(k) Applications Submitted by PRISMATIK DENTALCRAFT, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K162537 09/12/2016 CAD/CAMouflage Milling Block PRISMATIK DENTALCRAFT, INC.
K160425 02/16/2016 CAD/CAMouflage Milling Bock Prismatik Dentalcraft, Inc.
K130604 03/07/2013 UNIVERSAL PASTE STAINS AND GLAZE PRISMATIK DENTALCRAFT, INC.
K150872 04/01/2015 BruxZir Anterior Milling Blanks PRISMATIK DENTALCRAFT, INC.
K130924 04/03/2013 BRUXZIR SHADED PRISMATIK DENTALCRAFT, INC.
K121391 05/09/2012 INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS PRISMATIK DENTALCRAFT, INC.
K141211 05/09/2014 INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS PRISMATIK DENTALCRAFT, INC.
K121406 05/10/2012 INCLUSIVE TAPERED IMPLANT SYSTEM PRISMATIK DENTALCRAFT, INC.
K151375 05/22/2015 Inclusive Titanium Abutments compatible with: Hiossen HG Implant System PRISMATIK DENTALCRAFT, INC.
K141788 07/02/2014 OBSIDIAN MILLING BLOCKS PRISMATIK DENTALCRAFT, INC.
K151798 07/02/2015 Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System PRISMATIK DENTALCRAFT, INC.
K141887 07/14/2014 OBSIDIAN PRESS (ALL CERAMIC AND POM) PRISMATIK DENTALCRAFT, INC.
K153099 10/26/2015 INCLUSIVE TAPERED IMPLANT SYSTEM PRISMATIK DENTALCRAFT, INC.
K143330 11/20/2014 BruxZir Anterior PRISMATIK DENTALCRAFT, INC.
K133850 12/19/2013 CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) PRISMATIK DENTALCRAFT, INC.
K142115 08/04/2014 INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT PRISMATIK DENTALCRAFT, INC.
K142118 08/04/2014 INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE PRISMATIK DENTALCRAFT, INC.
K143353 11/24/2014 Hahn Tapered Implant System PRISMATIK DENTALCRAFT, INC.
K143515 12/11/2014 Inclusive« Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants PRISMATIK DENTALCRAFT, INC.
K242564 08/28/2024 Autoclavable Cassette (Glidewell HTÖ Implant Guided Surgical Kit, Glidewell HTÖ Implant Surgical Kit, GlidewellÖ Prosthetic Kit) Prismatik Dentalcraft, Inc.
K210694 03/08/2021 Silent Nite Sleep Appliance with the Glidewell Hinge Prismatik Dentalcraft, Inc.
K211069 04/12/2021 EndSnorZ Sleep Appliance Prismatik Dentalcraft, Inc.
K191222 05/07/2019 Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV Prismatik Dentalcraft, Inc.
K250302 02/03/2025 Flexible Partial Resin Prismatik Dentalcraft, Inc.
K231529 05/26/2023 CloudPoint FastDesign Chairside Prismatik Dentalcraft, Inc.
K213765 12/01/2021 Glidewell 3DP Denture Base Resin Prismatik Dentalcraft, Inc.
K223798 12/19/2022 Glidewell TuffSplintÖ Appliance Resin Prismatik Dentalcraft, Inc.
K214102 12/29/2021 Glidewell Appliance Resin, Hard/Soft Prismatik Dentalcraft, Inc.
K120858 03/21/2012 IMPLANT BAR PRISMATIK DENTALCRAFT, INC.
K121688 06/07/2012 MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM PRISMATIK DENTALCRAFT, INC.
K100781 03/19/2010 OBSIDIAN CERAMIC BLOCKS PRISMATIK DENTALCRAFT, INC.
K100932 04/05/2010 INCLUSIVE MINI IMPLANT PRISMATIK DENTALCRAFT, INC.
K100993 04/09/2010 INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS PRISMATIK DENTALCRAFT, INC.
K241493 05/28/2024 GlidewellÖ 3DP Denture Base Resin Prismatik Dentalcraft, Inc.
K170044 01/05/2017 Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System PRISMATIK DENTALCRAFT, INC.
K141923 07/16/2014 INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X PRISMATIK DENTALCRAFT, INC.
K191903 07/16/2019 BruxZir GT (Gum Tissue) Color Prismatik Dentalcraft, Inc.
K183270 11/23/2018 Silent Nite sl Prismatik Dentalcraft, Inc.
K231347 05/09/2023 BruxZirÖ TintEFX Coloring Liquid Prismatik Dentalcraft, Inc.
K234014 12/19/2023 Obsidian« NOW Prismatik Dentalcraft, Inc.
K160979 04/07/2016 Inclusive Abutments PRISMATIK DENTALCRAFT, INC.
K250223 01/27/2025 BruxZir« Esthetic NOW Prismatik Dentalcraft, Inc.
K240240 01/30/2024 Inclusive« Titanium Abutments compatible with: Keystone« Dental PrimaConnex«, Neodent« GM, Straumann« BLX, Implant Direct« Legacy«, Implant Direct« InterActive«, Implant Direct« RePlant« Implant Systems Prismatik Dentalcraft, Inc.
K220816 03/21/2022 BruxZir NOW Prismatik Dentalcraft, Inc.
K240882 04/01/2024 BruxZir« Esthetic Prismatik Dentalcraft, Inc.
K223496 11/21/2022 Inclusive« Titanium Abutments compatible with: Straumann« Bone Level SC, BioHorizons« Tapered Internal, MIS« C1 Implant Systems Prismatik Dentalcraft, Inc.
K200131 01/21/2020 BruxZir Steel Prismatik Dentalcraft, Inc.
K230262 01/31/2023 BruxZirÖ Incisal Coloring Liquid Prismatik Dentalcraft, Inc.
K220960 04/01/2022 BruxZir Opaque Coloring Liquid Prismatik Dentalcraft, Inc.
K231097 04/18/2023 Inclusive« Titanium Abutments compatible with: Neoss« ProActive« Narrow, Neoss« ProActive« Standard, MIS« SEVEN«, Zimmer« Eztetic« Implant Systems Prismatik Dentalcraft, Inc.
K231940 06/30/2023 BruxZir« NOW SRC Prismatik Dentalcraft, Inc.
K213425 10/21/2021 BruxZir Esthetic Prismatik Dentalcraft, Inc.
K240574 03/01/2024 BruxZir« Radiant Prismatik Dentalcraft, Inc.


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