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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 for PlanMill HT C3 C14/5 FDA UDI
Model / Reference
665875 FDA UDI
Description
IPS e.max CAD for PlanMill HT C3 C14/5 FDA UDI

Identifiers

Catalog Number
665875 FDA UDI
Primary DI / UDI-DI
DIVO6658751 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

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

Similar devices

Also classified as Dental appliance fabrication material, ceramic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 8e564df0-5ec5-4664-9f9b-8a5296c067e1 34 fields · synced May 30, 2026