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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 28 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1050-COM0064	FDA UDI	Class II	Active
Inclusive	70-1068-IMP0003	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0180	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0568	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0585	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0666	FDA UDI	Class II	Unknown
Silent Nite Sleep Appliance with Glidewell Hinge	SNGLHGADJ	FDA UDI	Class II	Active
Inclusive	70-1054-COM0047	FDA UDI	Class II	Active
Inclusive	70-1147-COM0074	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0034	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0629	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0040	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0162	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0093	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0246	FDA UDI	Class II	Active
BruxZir	4400189	FDA UDI	Class II	Active
Inclusive	70-1051-COM0092	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0096	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0010	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0023	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0316	FDA UDI	Class I	Active
ACE Surgical	307355	FDA UDI	Class I	Active
BruxZir	70-1160-BXA0002	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0130	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0292	FDA UDI	Class II	Active
Hahn	70-1153-PRC0074	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0048	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0461	FDA UDI	Class II	Active
Hahn	70-1153-PRC0064	FDA UDI	Class I	Active
Inclusive	70-1054-COM0004	FDA UDI	Class II	Active
Inclusive	70-1054-COM0012	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0405	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0020	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0164	FDA UDI	Class II	Active
Inclusive®	70-1178-COM0008	FDA UDI	Class II	Active
Hahn	70-1153-PRC0008	FDA UDI	Class II	Active
Hahn	70-1153-PRA0082	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0087	FDA UDI	Class II	Active
Inclusive	70-1054-COM0084	FDA UDI	Class I	Active
Inclusive	70-1056-COM0006	FDA UDI	Class I	Active
Hahn	70-1153-PRC0025	FDA UDI	Class I	Active
Inclusive®	70-1055-COM0063	FDA UDI	Class II	Active
BruxZir	70-1156-BXA0026	FDA UDI	Class II	Active
Glidewell HT™	70-1189-IMP0018	FDA UDI	Class II	Active
Inclusive	70-1176-COM0209	FDA UDI	Class I	Active
BruxZir	70-1156-BXA0019	FDA UDI	Class II	Active
BruxZir	70-1015-BRX0009	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0028	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0436	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0274	FDA UDI	Class I	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.