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Compules Tips Gun

FDA UDI

Class I (US FDA UDI)

by Dentsply De Trey GmbH

Identity

Trade Name
Compules Tips Gun FDA UDI
Generic Name
Dental material cartridge-plunging applicator, single-component FDA UDI
Device Name
Compules Tips Gun is an applicator gun for all Dentsply Sirona materials delivered in Compules Tips and Compula Tips. FDA UDI
Model / Reference
60665900 FDA UDI
Description
Compules Tips Gun is an applicator gun for all Dentsply Sirona materials delivered in Compules Tips and Compula Tips. FDA UDI

Identifiers

Catalog Number
60665900 FDA UDI
Primary DI / UDI-DI
D010606659001 FDA UDI
FDA Product Code
DZN FDA UDI
GMDN Term
Dental material cartridge-plunging applicator, single-component 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Compules Tips Gun 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 38060306-d14c-4080-a9ce-75ea3eeccecd 34 fields · synced Jun 6, 2026