Prismatik Dentalcraft, Inc.

Code	Device name	Class	Specialty	Clearances	Most recent
EIH	Powder, Porcelain	Class II	Dental	13	2026-07-30
NHA	Abutment, Implant, Dental, Endosseous	Class II	Dental	5	2025-11-18
EBI	—	—	—	3	2025-06-25
LRK	Device, Anti-Snoring	Class II	Dental	3	2023-11-14
MQC	—	—	—	2	2023-02-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	Class II	General Hospital	1	2025-03-21
PNP	Dental Abutment Design Software For Dental Laboratory	Class II	Dental	1	2024-03-14

Date	Severity	Status	Recall #	Product	Code	Reason
2025-09-30	Class II	Ongoing	Z-0417-2026	Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain 3.4/4.1/5.0/6.0 mm Mo…	—	Incorrect titanium screw, packaged with dental implant.
2025-04-14	Class II	Ongoing	Z-1856-2025	Glidewell HT Implant Twist Drill ¿1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code: +D7457071SRG02660/$$76254798/16D20250219…	—	Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.

Date	K-number	Device	Code	Class	Specialty
2026-07-30	K262239	Obsidian® Press Over Zirconia	EIH	Class II	Dental
2026-01-30	K254283	BruxZir® Shaded 16 PLUS	EIH	Class II	Dental
2025-11-18	K252582	Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems	NHA	Class II	Dental
2025-09-03	K252446	BruxZir® NOW	EIH	Class II	Dental
2025-06-25	K250302	Flexible Partial Resin	EBI	—	—
2025-03-21	K242564	Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit)	KCT	Class II	General Hospital
2025-02-25	K250223	BruxZir® Esthetic NOW	EIH	Class II	Dental
2024-09-12	K241493	Glidewell 3DP Denture Base Resin	EBI	—	—
2024-07-12	K240240	Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems	NHA	Class II	Dental
2024-05-15	K231940	BruxZir® NOW SRC	NHA	Class II	Dental
2024-05-01	K240882	BruxZir® Esthetic	EIH	Class II	Dental
2024-03-20	K240574	BruxZir® Radiant	EIH	Class II	Dental
2024-03-14	K231529	CloudPoint FastDesign Chairside	PNP	Class II	Dental
2024-02-27	K234014	Obsidian® NOW	EIH	Class II	Dental
2023-11-14	K233434	Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG)	LRK	Class II	Dental
2023-11-14	K231097	Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems	NHA	Class II	Dental
2023-09-26	K223496	Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems	NHA	Class II	Dental
2023-06-09	K231347	BruxZir TintEFX Coloring Liquid	EIH	Class II	Dental
2023-05-16	K230262	BruxZir Incisal Coloring Liquid	EIH	Class II	Dental
2023-02-17	K223798	Glidewell TuffSplint Appliance Resin	MQC	—	—
2022-08-02	K220816	BruxZir NOW	EIH	Class II	Dental
2022-06-29	K220960	BruxZir Opaque Coloring Liquid	EIH	Class II	Dental
2022-06-22	K213765	Glidewell 3DP Denture Base Resin	EBI	—	—
2022-02-23	K214102	Glidewell Appliance Resin, Hard/Soft	MQC	—	—
2021-11-17	K213425	BruxZir Esthetic	EIH	Class II	Dental
2021-10-26	K211069	EndSnorZ Sleep Appliance	LRK	Class II	Dental
2021-06-16	K210694	Silent Nite Sleep Appliance with the Glidewell Hinge	LRK	Class II	Dental
2020-06-10	K200131	BruxZir Steel	EIH	Class II	Dental

Clearance cadence by quarter

Product codes worked

Recalls (2)

All 510(k) clearances (28)