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HeraCeram Pastenopaker bleach, 2ml

FDA UDI

Class II (US FDA UDI)

by Kulzer, Inc.

Identity

Trade Name
HeraCeram Pastenopaker bleach, 2ml FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
Porcelain Powder for clinical use. FDA UDI
Model / Reference
66003360 FDA UDI
Description
Porcelain Powder for clinical use. FDA UDI

Identifiers

Catalog Number
66003360 FDA UDI
Primary DI / UDI-DI
J014660033600 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
Not 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

HeraCeram Pastenopaker bleach, 2ml by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kulzer, Inc.

Sources (1)

  • FDA UDI c637968d-f3e5-46ff-98a4-8e2c9af631ad 36 fields · synced May 31, 2026