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PRISMATIK DENTALCRAFT, INC.

Last updated September 17, 2026

Information

Country: US
Address: 2144 Michelson Drive, Irvine, CA, 92612
Website: —
LinkedIn: —
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Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3011649314
DUNS Number: —

Catalogue (5582)

Page 112 of 112

Device	Model / Reference	Registries	Class	Status
Glidewell TuffSplint™ Appliance Resin	K223798	FDA 510(k)	U	Active
BruxZir® Shaded 16 PLUS	K254283	FDA 510(k)	Class II	Active
Inclusive Titanium Abutments For Camlog Screw-Line Implants	K121391	FDA 510(k)	Class II	Active
Obsidian Press (all Ceramic And Pom)	K141887	FDA 510(k)	Class II	Active
Multi-Unit Abutments With Angulations 17 And 30 For Tapered Implant System	K121688	FDA 510(k)	Class II	Active
Inclusive Titanium Abutments compatible with: Hiossen HG Implant System	K151375	FDA 510(k)	Class II	Active
Inclusive Titanium Abutments For Astra Tech Osseospeed Implants	K100993	FDA 510(k)	Class II	Active
Inclusive Tapered Implant System	K153099	FDA 510(k)	Class II	Active
Glidewell 3DP Denture Base Resin	K213765	FDA 510(k)	Class II	Active
BruxZir® NOW SRC	K231940	FDA 510(k)	Class II	Active
Hahn Tapered Implant System	K143353	FDA 510(k)	Class II	Active
Universal Paste Stains And Glaze	K130604	FDA 510(k)	Class II	Active
Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)	K242564	FDA 510(k)	Class II	Active
BruxZir Anterior Milling Blanks	K150872	FDA 510(k)	Class II	Active
Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System	K170044	FDA 510(k)	Class II	Active
Obsidian Ceramic Blocks	K100781	FDA 510(k)	Class II	Active
BruxZir® NOW	K252446	FDA 510(k)	Class II	Active
CAD/CAMouflage Milling Block	K162537	FDA 510(k)	Class II	Active
BruxZir Opaque Coloring Liquid	K220960	FDA 510(k)	Class II	Active
BruxZir® Esthetic NOW	K250223	FDA 510(k)	Class II	Active
Inclusive Mini Implant	K100932	FDA 510(k)	Class II	Active
Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems	K223496	FDA 510(k)	Class II	Active
EndSnorZ Sleep Appliance	K211069	FDA 510(k)	Class II	Active
Camouflage Nanohybrid Composite (universal & Flowable)	K133850	FDA 510(k)	Class II	Active
BruxZir™ TintEFX Coloring Liquid	K231347	FDA 510(k)	Class II	Active
Inclusive Titanium Abutments Compatible With: Zimmer, Biomet 3i, And Nobel Biocare Implant	K142115	FDA 510(k)	Class II	Active
CloudPoint FastDesign Chairside	K231529	FDA 510(k)	Class II	Active
Flexible Partial Resin	K250302	FDA 510(k)	Class II	Active
BruxZir Steel	K200131	FDA 510(k)	Class II	Active
Obsidian Milling Blocks	K141788	FDA 510(k)	Class II	Active
Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants	K143515	FDA 510(k)	Class II	Active
Glidewell Appliance Resin, Hard/Soft	K214102	FDA 510(k)	U	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 30, 2025	Z-0417-2026	—	open, classified	Incorrect titanium screw, packaged with dental implant.
Apr 14, 2025	Z-1856-2025	—	open, classified	Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Aug 15, 2016	Z-2897-2016	—	terminated	Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.