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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 26 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1160-BXA0023	FDA UDI	Class II	Unknown
Glidewell HT™	70-1071-SRG0290	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0117	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0134	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0021	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0070	FDA UDI	Class II	Active
Inclusive	70-1176-COM0204	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0004	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0959	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0066	FDA UDI	Class I	Active
Hahn	70-1154-IMP0001	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0025	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0031	FDA UDI	Class II	Unknown
BruxZir	70-1119-BXS0116	FDA UDI	Class II	Unknown
BruxZir	70-1159-BXA0024	FDA UDI	Class II	Active
Inclusive	70-1047-COM0059	FDA UDI	Class II	Active
Inclusive	70-1173-COM0033	FDA UDI	Class II	Active
Capture	70-1031-CAP0022	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0941	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0131	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0956	FDA UDI	Class II	Active
Obsidian	70-1124-PUS0069	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0043	FDA UDI	Class I	Active
Inclusive	70-1054-COM0076	FDA UDI	Class II	Active
Inclusive	70-1139-COM0001	FDA UDI	Class II	Active
Inclusive	70-1052-COM0097	FDA UDI	Class I	Active
ACE Surgical	3035MUA	FDA UDI	Class II	Active
Capture	70-1030-CAP0004	FDA UDI	Class II	Active
Inclusive	70-1047-COM0016	FDA UDI	Class I	Active
Glidewell IH™	70-1072-PRC0075	FDA UDI	Class I	Active
Inclusive	70-1069-IMP0004	FDA UDI	Class II	Active
Inclusive	70-1054-COM0090	FDA UDI	Class I	Active
Inclusive	70-1147-COM0013	FDA UDI	Class I	Active
Inclusive	70-1048-COM0031	FDA UDI	Class II	Active
Inclusive	70-1050-COM0152	FDA UDI	Class I	Active
Inclusive	70-1050-COM0044	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0016	FDA UDI	Class II	Active
BioTemps	70-1181-MIL0092	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0024	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0217	FDA UDI	Class II	Active
Inclusive	70-1053-COM0058	FDA UDI	Class II	Active
Hahn	70-1071-SRG0177	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0036	FDA UDI	Class II	Active
Hahn	70-1071-SRG0194	FDA UDI	Class I	Active
Inclusive	70-1147-COM0011	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0094	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0257	FDA UDI	Class II	Unknown
BruxZir NOW	70-1184-NOW0001	FDA UDI	Class II	Unknown
Inclusive	70-1052-COM0059	FDA UDI	Class I	Active
Glidewell™ 3DP Denture Teeth Resin Shade A4	70-1164-GBD0010	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.