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PRISMATIK DENTALCRAFT, INC.

Last updated September 17, 2026

What PRISMATIK DENTALCRAFT, INC. makes

Prismatik Dentalcraft produces ceramic materials for dental appliance fabrication, including preformed temporary and permanent suprastructures for dental implants. Their portfolio also includes intraoral-scanning abutment analogs, reusable dental drill bits, and single-use dental prosthesis abutment screws. The company offers complete dental implant systems and analog components for implant planning and fitting.

Their devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

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

Catalogue (5582)

Page 75 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1156-BXA0031	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0584	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0908	FDA UDI	Class II	Active
BruxZir Esthetic NOW	70-1182-NOW0018	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0070	FDA UDI	Class I	Active
Glidewell Zirconia Primer	70-1198-PVC0002	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0013	FDA UDI	Class I	Active
BruxZir	70-1155-BXA0029	FDA UDI	Class II	Active
Inclusive	70-1051-COM0109	FDA UDI	Class I	Active
BruxZir	70-1010-BRX0095	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0079	FDA UDI	Class I	Active
Glidewell IH™	70-1072-PRC0069	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0068	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0006	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0078	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0031	FDA UDI	Class II	Active
Inclusive	70-1054-COM0169	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0115	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0493	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0012	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0042	FDA UDI	Class II	Active
Tap	TAPF	FDA UDI	Class II	Active
BruxZir	4400195	FDA UDI	Class II	Active
Hahn	70-1071-SRG0207	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0821	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0048	FDA UDI	Class I	Active
BruxZir®	70-1184-RAD0033	FDA UDI	Class II	Active
Inclusive	70-1050-COM0086	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0178	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0099	FDA UDI	Class II	Active
Inclusive	70-1051-COM0238	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0143	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0544	FDA UDI	Class II	Active
Obsidian	70-1122-SHS0101	FDA UDI	Class II	Unknown
Glidewell HT™	70-1190-PRA0044	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0060	FDA UDI	Class I	Active
BruxZir®	70-1184-RAD0030	FDA UDI	Class II	Active
Inclusive	70-1176-COM0238	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0223	FDA UDI	Class II	Active
Inclusive	70-1048-COM0155	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0163	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0134	FDA UDI	Class I	Active
Inclusive®	70-1195-COM0018	FDA UDI	Class I	Active
Inclusive	70-1176-COM0401	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0192	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0153	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0011	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0127	FDA UDI	Class II	Active
Inclusive	70-1051-COM0250	FDA UDI	Class I	Active
Obsidian	70-1122-OMB0008	FDA UDI	Class II	Active

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Authorised Representatives

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Authorities

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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.