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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 86 of 112

Device	Model / Reference	Registries	Class	Status
Glidewell HT™	70-1190-PRA0034	FDA UDI	Class I	Active
Inclusive	70-1051-COM0181	FDA UDI	Class II	Active
Inclusive	70-1052-COM0053	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0010	FDA UDI	Class II	Active
Inclusive	70-1051-COM0063	FDA UDI	Class II	Active
Inclusive®	70-1193-COM0006	FDA UDI	Class I	Active
Inclusive®	70-1195-COM0002	FDA UDI	Class II	Active
Inclusive®	70-1056-COM0019	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0011	FDA UDI	Class I	Active
BruxZir	70-1015-BRX0006	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0028	FDA UDI	Class II	Active
Inclusive	70-1051-COM0123	FDA UDI	Class I	Active
Inclusive	70-1047-COM0116	FDA UDI	Class I	Active
BruxZir	4400183	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0039	FDA UDI	Class II	Active
Inclusive	70-1047-COM0150	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0108	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0026	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0085	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0264	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0286	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0529	FDA UDI	Class II	Unknown
Inclusive®	70-1190-COM0022	FDA UDI	Class I	Active
Inclusive	70-1047-COM0102	FDA UDI	Class II	Active
Camouflage	70-1152-CMF0011	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0025	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0102	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0002	FDA UDI	Class I	Active
Inclusive	70-1052-COM0082	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0076	FDA UDI	Class II	Active
Inclusive	70-1051-COM0206	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0117	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0546	FDA UDI	Class II	Active
Hahn	70-1153-PRC0065	FDA UDI	Class I	Active
Inclusive	70-1047-COM0101	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0092	FDA UDI	Class I	Active
Glidewell IH™	70-1072-PRC0082	FDA UDI	Class I	Active
Glidewell IH™	70-1071-SRG0427	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0078	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0012	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0016	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0214	FDA UDI	Class II	Active
Inclusive®	70-1052-COM0162	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0336	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0255	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0033	FDA UDI	Class I	Active
Inclusive®	70-1195-COM0003	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0344	FDA UDI	Class I	Active
Glidewell IH™	70-1071-SRG0442	FDA UDI	Class I	Active
BruxZir®	70-1184-RAD0001	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

No authorised representatives on record.

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Authorities

Not available yet.

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.