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IvoBase HI / IvoBase Hybrid

FDA UDI

Class II (US FDA UDI)

by Ivoclar Vivadent Aktiengesellschaft

Identity

Trade Name
IvoBase HI / IvoBase Hybrid FDA UDI
Generic Name
Denture base resin kit FDA UDI
Device Name
IvoBase HI Kit 20 Pink-V Implant FDA UDI
Model / Reference
628892AN FDA UDI
Description
IvoBase HI Kit 20 Pink-V Implant FDA UDI

Identifiers

Catalog Number
628892AN FDA UDI
Primary DI / UDI-DI
07615208009446 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Denture base resin kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Denture base resin kit

IvoBase HI / IvoBase Hybrid by Ivoclar Vivadent Aktiengesellschaft — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Denture base resin kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ivoclar Vivadent Aktiengesellschaft

Sources (1)

  • FDA UDI 57504982-7e22-46df-8d54-39013c385e71 34 fields · synced May 30, 2026