IPS e.max CAD

FDA UDI

Class II (US FDA UDI)

by Ivoclar Vivadent Aktiengesellschaft

Identity

Trade Name: IPS e.max CAD FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: IPS e.max CAD CEREC/inLab LT A2 C14/5 FDA UDI
Model / Reference: 605329US FDA UDI
Description: IPS e.max CAD CEREC/inLab LT A2 C14/5 FDA UDI

Identifiers

Catalog Number: 605329US FDA UDI
Primary DI / UDI-DI: DIVO605329US1 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

IPS e.max CAD by Ivoclar Vivadent Aktiengesellschaft — 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: Ivoclar Vivadent Aktiengesellschaft

Sources (1)

FDA UDI e48939ec-8999-489a-a106-3948203bd012 34 fields · synced Jun 1, 2026