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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 110 of 112

Device	Model / Reference	Registries	Class	Status
Glidewell HT™	70-1190-PRA0008	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0431	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0103	FDA UDI	Class II	Active
Inclusive	70-1047-COM0178	FDA UDI	Class I	Active
BruxZir	70-1015-BRX0007	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0083	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0288	FDA UDI	Class I	Active
Inclusive	70-1147-COM0045	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0502	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0063	FDA UDI	Class II	Active
Glidewell IH™	70-1072-PRC0081	FDA UDI	Class I	Active
Glidewell IH™	70-1206-IMP0010	FDA UDI	Class II	Active
ACE Surgical	3010432	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0137	FDA UDI	Class I	Active
Glidewell HT™	70-1190-IMP0009	FDA UDI	Class II	Active
Ema	EMA	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0358	FDA UDI	Class I	Active
Glidewell IH™	70-1071-SRG0430	FDA UDI	Class I	Active
Glidewell IH™	70-1074-PRS0091	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0027	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRC0051	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0355	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0342	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0068	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0396	FDA UDI	Class II	Active
Glidewell HT™	70-1174-SRG0030	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0416	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0410	FDA UDI	Class I	Active
ACE Surgical	2035MU17	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0339	FDA UDI	Class I	Active
Glidewell IH™	70-1074-PRS0095	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0130	FDA UDI	Class I	Active
ACE Surgical	MUS0043	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0295	FDA UDI	Class I	Active
Silent Nite 3D Sleep Appliance	MA-PC-SD-UA	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0434	FDA UDI	Class I	Active
Glidewell HT™	70-1189-IMP0022	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0015	FDA UDI	Class II	Active
Dream TAP	TAPD	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRS0009	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0046	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0006	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0048	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRS0013	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0446	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0362	FDA UDI	Class I	Active
ACE Surgical	2010352	FDA UDI	Class I	Active
Glidewell IH™	70-1206-IMP0020	FDA UDI	Class II	Active
Glidewell™ 3DP Denture Teeth Resin Shade A2	70-1164-GBD0005	FDA UDI	Class II	Active
ACE Surgical	207353	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.