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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 81 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1156-BXA0004	FDA UDI	Class II	Active
Inclusive	70-1054-COM0177	FDA UDI	Class I	Active
Inclusive	70-1054-COM0096	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0062	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0054	FDA UDI	Class I	Active
Inclusive	70-1074-PRS0071	FDA UDI	Class I	Active
Inclusive	70-1070-IMP0012	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0021	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0075	FDA UDI	Class II	Active
Comfort Splint	COMSPL	FDA UDI	U	Active
Inclusive®	70-1190-COM0117	FDA UDI	Class I	Active
Glidewell™ 3DP Denture Base Resin - Shade G4	70-1164-GBD0003	FDA UDI	Class II	Active
Inclusive	70-1054-COM0094	FDA UDI	Class I	Active
Camouflage	70-1151-CMU0006	FDA UDI	Class II	Unknown
Inclusive®	70-1055-COM0081	FDA UDI	Class I	Active
Inclusive	70-1053-COM0072	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0215	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0204	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0042	FDA UDI	Class II	Active
BruxZir	70-1156-BXA0009	FDA UDI	Class II	Active
Glidewell IH™	70-1074-PRS0092	FDA UDI	Class II	Active
BruxZir	70-1015-BRX0010	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0027	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0044	FDA UDI	Class I	Active
Capture	70-1030-CAP0001	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0064	FDA UDI	Class II	Active
Glidewell IH™	70-1074-PRS0082	FDA UDI	Class II	Active
Inclusive	70-1048-COM0160	FDA UDI	Class II	Active
Inclusive	70-1147-COM0061	FDA UDI	Class I	Active
Inclusive	70-1047-COM0082	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0050	FDA UDI	Class I	Active
BruxZir NOW	70-1167-NOW0104	FDA UDI	Class II	Active
BruxZir	70-1167-NOW0023	FDA UDI	Class II	Unknown
BruxZir	70-1156-BXA0001	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0046	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0012	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0174	FDA UDI	Class II	Active
BruxZir NOW	70-1184-NOW0008	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0035	FDA UDI	Class I	Active
Hahn	70-1153-PRC0061	FDA UDI	Class I	Active
Camouflage	70-1152-CMF0012	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0265	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0065	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0090	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0081	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0282	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0387	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0028	FDA UDI	Class II	Unknown
Camouflage	70-1152-CMF0001	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0014	FDA UDI	Class II	Active

Related Companies

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.