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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 83 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1138-BSA0512	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0918	FDA UDI	Class II	Active
Inclusive	70-1048-COM0204	FDA UDI	Class II	Active
Glidewell HT™	70-1190-IMP0013	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0486	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0901	FDA UDI	Class II	Unknown
Inclusive	70-1047-COM0188	FDA UDI	Class I	Unknown
Hahn	70-1153-PRA0124	FDA UDI	Class II	Active
Inclusive	70-1048-COM0087	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0062	FDA UDI	Class I	Active
BruxZir®	70-1184-RAD0004	FDA UDI	Class II	Active
Hahn	70-1071-SRG0186	FDA UDI	Class I	Active
Inclusive	70-1054-COM0154	FDA UDI	Class II	Active
Hahn	70-1071-SRG0227	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0149	FDA UDI	Class II	Unknown
Inclusive®	70-1056-COM0038	FDA UDI	Class I	Active
Inclusive	70-1047-COM0209	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0545	FDA UDI	Class II	Active
BruxZir	70-1185-BXP0574	FDA UDI	Class II	Active
Inclusive	70-1052-COM0083	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0104	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0040	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0173	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0019	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0018	FDA UDI	Class II	Active
Hahn	70-1071-SRG0211	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0028	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0359	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0376	FDA UDI	Class I	Active
Inclusive	70-1153-PRA0025	FDA UDI	Class I	Unknown
Inclusive	70-1051-COM0046	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0034	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0104	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0106	FDA UDI	Class II	Active
Inclusive	70-1147-COM0084	FDA UDI	Class I	Active
Inclusive	70-1139-COM0029	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0302	FDA UDI	Class II	Active
BruxZir	70-1167-NOW0029	FDA UDI	Class II	Unknown
Inclusive	70-1049-COM0055	FDA UDI	Class II	Active
Inclusive	70-1048-COM0019	FDA UDI	Class I	Active
BruxZir	70-1167-NOW0026	FDA UDI	Class II	Unknown
Glidewell HT™	70-1071-SRG0268	FDA UDI	Class I	Active
Inclusive	70-1050-COM0108	FDA UDI	Class I	Unknown
Obsidian	70-1122-OMB0005	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0310	FDA UDI	Class II	Unknown
BruxZir	70-1119-BXS0108	FDA UDI	Class II	Active
BruxZir®	70-1182-NOW0071	FDA UDI	Class II	Active
Inclusive	70-1139-COM0036	FDA UDI	Class I	Active
Inclusive	70-1054-COM0086	FDA UDI	Class I	Active
BruxZir	70-1159-BXA0009	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.