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PRISMATIK DENTALCRAFT, INC.

Last updated September 17, 2026

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 96 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir Esthetic	70-1183-BEP0107	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0008	FDA UDI	Class II	Active
Inclusive	70-1051-COM0166	FDA UDI	Class I	Active
Hahn	70-1153-PRS0004	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0241	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0042	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0020	FDA UDI	Class I	Active
Obsidian	70-1122-SHS0096	FDA UDI	Class II	Unknown
BruxZir	70-1117-BXS0106	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0044	FDA UDI	Class II	Active
Inclusive	70-1052-COM0067	FDA UDI	Class I	Unknown
BruxZir	70-1138-BSA0528	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0285	FDA UDI	Class II	Unknown
Inclusive	70-1052-COM0084	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0339	FDA UDI	Class II	Unknown
BruxZir	4400174	FDA UDI	Class II	Active
Inclusive	70-1047-COM0117	FDA UDI	Class II	Active
Inclusive	70-1049-COM0063	FDA UDI	Class I	Active
Inclusive	70-1049-COM0053	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0121	FDA UDI	Class II	Unknown
BruxZir	70-1167-NOW0010	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0030	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0015	FDA UDI	Class II	Unknown
Inclusive	70-1051-COM0113	FDA UDI	Class I	Active
Newport Biologics Resorbable Collagen Membrane 46	70-BIO-3040R46	FDA UDI	Class II	Active
Inclusive	70-1048-COM0165	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0073	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0117	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0007	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0169	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0544	FDA UDI	Class II	Active
BruxZir	70-1185-BXP0581	FDA UDI	Class II	Active
Inclusive	70-1176-COM0258	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0217	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0136	FDA UDI	Class II	Active
Glidewell IH™	70-1072-PRC0090	FDA UDI	Class I	Active
Hahn	70-1153-PRA0059	FDA UDI	Class II	Active
Inclusive	70-1176-COM0255	FDA UDI	Class II	Active
Hahn	70-1154-IMP0018	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0635	FDA UDI	Class II	Active
Inclusive	70-1054-COM0107	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0266	FDA UDI	Class II	Unknown
Hahn	70-1153-PRA0056	FDA UDI	Class II	Active
BruxZir Esthetic NOW	70-1182-NOW0004	FDA UDI	Class II	Active
Inclusive	70-1147-COM0079	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0065	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0075	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0061	FDA UDI	Class II	Active
Inclusive	70-1047-COM0006	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0511	FDA UDI	Class II	Active

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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.