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Capsule Extruder 2

FDA UDI

Class I (US FDA UDI)

by Dentsply De Trey GmbH

Identity

Trade Name
Capsule Extruder 2 FDA UDI
Generic Name
Dental material cartridge-plunging applicator, single-component FDA UDI
Device Name
Capsule Extruder 2 is the device designed for extrusion and direct application of ChemFil® Rock restorative capsules FDA UDI
Model / Reference
60606596 FDA UDI
Description
Capsule Extruder 2 is the device designed for extrusion and direct application of ChemFil® Rock restorative capsules FDA UDI

Identifiers

Catalog Number
60606596 FDA UDI
Primary DI / UDI-DI
D010606065961 FDA UDI
FDA Product Code
KXR FDA UDI
GMDN Term
Dental material cartridge-plunging applicator, single-component FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3140 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 17.5 Centimeter FDA UDI

Category: Dental material cartridge-plunging applicator, single-component

Capsule Extruder 2 by Dentsply De Trey GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentsply De Trey GmbH

Sources (1)

  • FDA UDI 26f8325f-cd75-4a8a-96cb-fe2413accab8 36 fields · synced Jun 8, 2026