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Extruder

FDA UDI

Class I (US FDA UDI)

by Kerr Corporation

Identity

Trade Name
Extruder FDA UDI
Generic Name
Dental material cartridge-plunging applicator, two-component, manual FDA UDI
Device Name
For 50ml Cartridge Systems FDA UDI
Model / Reference
28747 FDA UDI
Description
For 50ml Cartridge Systems FDA UDI

Identifiers

Primary DI / UDI-DI
00841396117336 FDA UDI
FDA Product Code
DZN FDA UDI
GMDN Term
Dental material cartridge-plunging applicator, two-component, manual FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental material cartridge-plunging applicator, two-component, manual

Extruder by Kerr Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental material cartridge-plunging applicator, two-component, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kerr Corporation

Sources (1)

  • FDA UDI eeb8495f-0263-44db-9e24-791d880c73e7 34 fields · synced Jun 8, 2026