Triceram®

FDA UDI

Class II (US FDA UDI)

by Dentaurum

Identity

Trade Name: Triceram® FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: Triceram® opaque B2, 15g / dental ceramic material FDA UDI
Model / Reference: 292-222-30 FDA UDI
Description: Triceram® opaque B2, 15g / dental ceramic material FDA UDI

Identifiers

Primary DI / UDI-DI: J011292222300 FDA UDI
510(k) Number: K011428 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

Yes

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

FDA UDI

Category: Dental appliance fabrication material, ceramic

Triceram® by Dentaurum — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K011428 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: Dentaurum

Sources (1)

FDA UDI dcc7996f-4f12-4f95-ad4b-3a5f3734c40d 36 fields · synced May 30, 2026