Prismatik Dentalcraft, Inc.
Prismatik Dentalcraft, Inc. holds FDA 510(k) medical device clearances, first cleared 2010, most recent 2026, with 3 FDA device recalls on record.
Top product codes for Prismatik Dentalcraft, Inc.
FDA recalls by Prismatik Dentalcraft, Inc.
- Z-0417-2026 — Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Model/Catalog Number: 70-1047-COM0117
- Z-1856-2025 — Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219V The Glidewell HT" Implant Twist Drill is indicated to prepare the site for placement of endosseous dental implants when tissue contact will last less than 1 hour. The Glidewell HT" Implant Twist Drill is used to remove bone from osteotomy during dental implant placement. The initial Twist Drill is used to deepen the osteotomy and establish the trajectory of subsequent drills in the placement of a dental implant. The large Twist Drill is stepped to accmmodate the tapered design of the implant and is available in lengths corresponding to the availble implant lengths. Drill length is calculated to indicate where the top of the implant will reside when fully seated to that depth. The Twist Drill is machined from stainless steel.
- Z-2897-2016 — BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Prismatik Dentalcraft, Inc.
- K261802 — Glidewell Denture Base Resin
- K262239 — Obsidian® Press Over Zirconia
- K254283 — BruxZir® Shaded 16 PLUS
- K252582 — Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems
- K252446 — BruxZir® NOW
- 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
- K231529 — CloudPoint FastDesign Chairside
- K234014 — Obsidian® NOW
- K231097 — Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems
- K233434 — Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG)
- K223496 — Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems
- K231347 — BruxZir TintEFX Coloring Liquid
- K230262 — BruxZir Incisal Coloring Liquid
- K223798 — Glidewell TuffSplint Appliance Resin
- K220816 — BruxZir NOW
- K220960 — BruxZir Opaque Coloring Liquid
- K213765 — Glidewell 3DP Denture Base Resin
- K214102 — Glidewell Appliance Resin, Hard/Soft
- K213425 — BruxZir Esthetic
- K211069 — EndSnorZ Sleep Appliance
- K210694 — Silent Nite Sleep Appliance with the Glidewell Hinge
- K200131 — BruxZir Steel
- K191903 — BruxZir GT (Gum Tissue) Color
- K191222 — Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV
- K183270 — Silent Nite sl
- K170044 — Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
- K162537 — CAD/CAMouflage Milling Block
- K160979 — Inclusive Abutments
- K160425 — CAD/CAMouflage Milling Bock
- K153099 — INCLUSIVE TAPERED IMPLANT SYSTEM
- K151798 — Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
- K151375 — Inclusive Titanium Abutments compatible with: Hiossen HG Implant System
- K143515 — Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants
- K150872 — BruxZir Anterior Milling Blanks
- K143353 — Hahn Tapered Implant System
- K141923 — INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X
- K143330 — BruxZir Anterior
- K142118 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE
- K142115 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL BIOCARE IMPLANT
- K141887 — OBSIDIAN PRESS (ALL CERAMIC AND POM)
- K141211 — INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS
- K141788 — OBSIDIAN MILLING BLOCKS
- K133850 — CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
- K130604 — UNIVERSAL PASTE STAINS AND GLAZE
- K130924 — BRUXZIR SHADED
- K121406 — INCLUSIVE TAPERED IMPLANT SYSTEM
- K121391 — INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS
- K120858 — IMPLANT BAR
- K121688 — MULTI-UNIT ABUTMENTS WITH ANGULATIONS 17 AND 30 FOR TAPERED IMPLANT SYSTEM
- K100993 — INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS
- K100932 — INCLUSIVE MINI IMPLANT
- K100781 — OBSIDIAN CERAMIC BLOCKS
Data sourced from openFDA. This site is unofficial and independent of the FDA.