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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 84 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1010-BRX0177	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0070	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0018	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0140	FDA UDI	Class II	Active
Inclusive	70-1139-COM0021	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0061	FDA UDI	Class II	Active
ACE Surgical	MU0016	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0548	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0467	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0565	FDA UDI	Class II	Active
Glidewell IH™	70-1074-PRS0104	FDA UDI	Class I	Active
Inclusive	70-1147-COM0100	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0031	FDA UDI	Class II	Active
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0020	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0002	FDA UDI	Class II	Active
Biotemps	70-1181-MIL0032	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0123	FDA UDI	Class II	Active
Inclusive	70-1139-COM0070	FDA UDI	Class I	Active
Inclusive	70-1051-COM0286	FDA UDI	Class I	Active
Inclusive®	70-1055-COM0079	FDA UDI	Class I	Active
Inclusive	70-1176-COM0394	FDA UDI	Class II	Active
Hahn	70-1153-PRC0069	FDA UDI	Class I	Active
BruxZir	70-1116-BXS0077	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0012	FDA UDI	Class II	Active
Inclusive	70-1047-COM0013	FDA UDI	Class I	Active
Inclusive	70-1173-COM0014	FDA UDI	Class I	Active
Inclusive	70-1047-COM0140	FDA UDI	Class II	Active
Inclusive	70-1053-COM0044	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0169	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0093	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRC0047	FDA UDI	Class I	Active
BruxZir	70-1157-BXA0020	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0088	FDA UDI	Class II	Active
Inclusive	70-1051-COM0275	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0109	FDA UDI	Class II	Active
Inclusive	70-1139-COM0044	FDA UDI	Class II	Active
Inclusive	70-1047-COM0008	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0033	FDA UDI	Class I	Active
Inclusive	70-1047-COM0113	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0126	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0026	FDA UDI	Class I	Active
Camouflage	70-1151-CMU0013	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0105	FDA UDI	Class II	Active
Hahn	70-1153-IMP0001	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0119	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0152	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0004	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0121	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0020	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0173	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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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.