ICE Stains 3D Blue Lightning (10 g)

FDA UDI

Class II (US FDA UDI)

by Zirkonzahn GmbH

Identity

Trade Name: ICE Stains 3D Blue Lightning (10 g) FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: Content: 10 g Stain and glaze firing can also be done in one step by working with the glazing mass directly on the case. FDA UDI
Model / Reference: MFAC2302 FDA UDI
Description: Content: 10 g Stain and glaze firing can also be done in one step by working with the glazing mass directly on the case. FDA UDI

Identifiers

Primary DI / UDI-DI: D800MFAC2302 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, ceramic

ICE Stains 3D Blue Lightning (10 g) by Zirkonzahn GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Zirkonzahn GmbH

Sources (1)

FDA UDI 7432f5e3-134f-401c-be08-95c7f3756e00 34 fields · synced Jun 8, 2026