BruxZir™ Opaque Coloring Liquid

FDA UDI

Class II (US FDA UDI)

by Prismatik Dentalcraft, Inc.

Identity

Trade Name: BruxZir™ Opaque Coloring Liquid FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: BruxZir™ Opaque Coloring Liquid - Opaq FDA UDI
Model / Reference: 70-1123-BRX0004 FDA UDI
Description: BruxZir™ Opaque Coloring Liquid - Opaq FDA UDI

Identifiers

Catalog Number: 70-1123-BRX0004 FDA UDI
Primary DI / UDI-DI: D745701123BRX00040 FDA UDI
510(k) Number: K220960 FDA UDI
FDA Product Code: EIH FDA UDI
GMDN Term: Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, ceramic

BruxZir™ Opaque Coloring Liquid by Prismatik Dentalcraft, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K220960 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Prismatik Dentalcraft, Inc.

Sources (1)

FDA UDI d9677104-c206-4438-aceb-12b07ad97bf5 36 fields · synced May 31, 2026