Medical Device Manufacturer · US , Newport Beach , CA

Prismatik Dentalcraft, Inc. - FDA 510(k) Cleared Devices

57 submissions · 57 cleared · Since 2010
57
Total
57
Cleared
0
Denied
56 devices
26-50 of 56
Cleared Jun 10, 2020
BruxZir Steel
K200131 · EIH
Dental · 141d
Cleared Nov 22, 2019
BruxZir GT (Gum Tissue) Color
K191903 · EIH
Dental · 129d
Cleared Aug 05, 2019
Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech...
K191222 · NHA
Dental · 90d
Cleared Jul 17, 2019
Silent Nite sl
K183270 · LRK
Dental · 236d
Cleared Jun 06, 2017
Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
K170044 · NHA
Dental · 152d
Cleared Nov 16, 2016
CAD/CAMouflage Milling Block
K162537 · EBF
Dental · 65d
Cleared Nov 04, 2016
Inclusive Abutments
K160979 · NHA
Dental · 211d
Cleared Jul 15, 2016
CAD/CAMouflage Milling Bock
K160425 · EBF
Dental · 150d
Cleared May 23, 2016
INCLUSIVE TAPERED IMPLANT SYSTEM
K153099 · DZE
Dental · 210d
Cleared Nov 16, 2015
Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
K151798 · NHA
Dental · 137d
Cleared Oct 07, 2015
Inclusive Titanium Abutments compatible with: Hiossen HG Implant System
K151375 · NHA
Dental · 138d
Cleared Oct 01, 2015
Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i...
K143515 · NHA
Dental · 294d
Cleared Jul 02, 2015
BruxZir Anterior Milling Blanks
K150872 · EIH
Dental · 92d
Cleared Apr 02, 2015
Hahn Tapered Implant System
K143353 · DZE
Dental · 129d
Cleared Jan 06, 2015
INCLUSIVE TITANIUM ABUTMENTS, COMPATIBLE WITH DENTSPLY IMPLANTS ANKYLOS C/X
K141923 · NHA
Dental · 174d
Cleared Dec 15, 2014
BruxZir Anterior
K143330 · EIH
Dental · 25d
Cleared Nov 25, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL...
K142118 · NHA
Dental · 113d
Cleared Nov 13, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: ZIMMER, BIOMET 3I, AND NOBEL...
K142115 · NHA
Dental · 101d
Cleared Nov 06, 2014
OBSIDIAN PRESS (ALL CERAMIC AND POM)
K141887 · EIH
Dental · 115d
Cleared Oct 22, 2014
INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH STRAUMANN TISSUE LEVEL IMPLANTS
K141211 · NHA
Dental · 166d
Cleared Aug 20, 2014
OBSIDIAN MILLING BLOCKS
K141788 · EIH
Dental · 49d
Cleared Jun 04, 2014
CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
K133850 · EBF
Dental · 167d
Cleared Sep 12, 2013
UNIVERSAL PASTE STAINS AND GLAZE
K130604 · EIH
Dental · 189d
Cleared May 16, 2013
BRUXZIR SHADED
K130924 · EIH
Dental · 43d
Cleared Feb 22, 2013
INCLUSIVE TAPERED IMPLANT SYSTEM
K121406 · DZE
Dental · 288d
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