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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 34 of 112

Device	Model / Reference	Registries	Class	Status
Hahn	70-1153-PRA0087	FDA UDI	Class II	Active
Inclusive	70-1051-COM0204	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0235	FDA UDI	Class II	Active
Inclusive	70-1051-COM0221	FDA UDI	Class I	Unknown
BruxZir	70-1117-BXS0110	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0037	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0171	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0143	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0228	FDA UDI	Class II	Unknown
Inclusive	70-1052-COM0152	FDA UDI	Class I	Active
Inclusive	70-1176-COM0256	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0711	FDA UDI	Class II	Unknown
Inclusive	70-1051-COM0219	FDA UDI	Class I	Unknown
Glidewell IH™	70-1206-IMP0016	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0090	FDA UDI	Class II	Active
Inclusive	70-1050-COM0091	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0895	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0722	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0002	FDA UDI	Class II	Active
Inclusive	70-1048-COM0149	FDA UDI	Class II	Active
Hahn	70-1153-PRC0001	FDA UDI	Class II	Active
Capture	70-1031-CAP0027	FDA UDI	Class II	Active
Inclusive	70-1176-COM0257	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0360	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0130	FDA UDI	Class II	Active
Inclusive	70-1053-COM0096	FDA UDI	Class I	Active
BruxZir	70-1159-BXA0003	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0055	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0062	FDA UDI	Class I	Active
Inclusive	70-1074-PRS0028	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0058	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0097	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0149	FDA UDI	Class II	Active
EndSnorZ Sleep Appliance	ENDSNZ	FDA UDI	Class II	Active
Glidewell IH™	70-1074-PRS0088	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0129	FDA UDI	Class II	Active
Inclusive	70-1147-COM0075	FDA UDI	Class II	Active
Inclusive	70-1048-COM0139	FDA UDI	Class II	Active
BruxZir	70-1015-BRX0004	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0043	FDA UDI	Class II	Active
Inclusive	70-1052-COM0004	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0121	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0009	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0138	FDA UDI	Class II	Active
Inclusive	70-1048-COM0156	FDA UDI	Class II	Active
BruxZir™ TintEFX Coloring Liquid	70-1123-BRX0030	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0224	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0062	FDA UDI	Class II	Active
Inclusive	70-1052-COM0001	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0054	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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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.