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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 95 of 112

Device	Model / Reference	Registries	Class	Status
Camouflage	70-1152-CMF0017	FDA UDI	Class II	Active
BruxZir®	70-1182-NOW0067	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0021	FDA UDI	Class II	Unknown
Inclusive	70-1055-COM0048	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0029	FDA UDI	Class I	Active
Obsidian	70-1124-PUS0059	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0096	FDA UDI	Class I	Active
Inclusive	70-1050-COM0146	FDA UDI	Class II	Active
Inclusive	70-1050-COM0065	FDA UDI	Class II	Active
Inclusive	70-1047-COM0014	FDA UDI	Class I	Active
BruxZir	70-1117-BXS0025	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0105	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0029	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0105	FDA UDI	Class II	Active
BruxZir	70-1156-BXA0034	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0117	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0181	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0142	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0017	FDA UDI	Class I	Active
BruxZir NOW	70-1167-NOW0074	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0053	FDA UDI	Class II	Active
Camouflage	70-1152-CMF0013	FDA UDI	Class II	Active
Inclusive	70-1176-COM0221	FDA UDI	Class II	Active
Inclusive	70-1147-COM0072	FDA UDI	Class II	Active
BruxZir	70-1015-BRX0011	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0027	FDA UDI	Class I	Active
Inclusive	70-1048-COM0090	FDA UDI	Class II	Active
Inclusive	70-1049-COM0060	FDA UDI	Class II	Active
BruxZir	70-1175-BZA0016	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0011	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0001	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0179	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0123	FDA UDI	Class II	Active
Inclusive	70-1051-COM0064	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0004	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0048	FDA UDI	Class II	Active
BruxZir™ TintEFX Coloring Liquid	70-1123-BRX0039	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0274	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0029	FDA UDI	Class II	Active
Inclusive	70-1153-PRA0098	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0019	FDA UDI	Class I	Active
CAMouflage	70-1000-CMN0039	FDA UDI	Class II	Active
Inclusive	70-1176-COM0253	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0050	FDA UDI	Class I	Active
Inclusive	70-1050-COM0047	FDA UDI	Class II	Active
Inclusive	70-1070-IMP0029	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0043	FDA UDI	Class I	Active
Inclusive®	70-1190-COM0012	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0030	FDA UDI	Class I	Active
BruxZir	70-1156-BXA0005	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.