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digit® Targeted Delivery System

FDA UDI

Class I (US FDA UDI)

by Dentsply International

Identity

Trade Name
digit® Targeted Delivery System FDA UDI
Generic Name
Dental material cartridge-plunging applicator, two-component, electric FDA UDI
Device Name
digit® Syringe Dispenser Refill FDA UDI
Model / Reference
678020 FDA UDI
Description
digit® Syringe Dispenser Refill FDA UDI

Identifiers

Catalog Number
678020 FDA UDI
Primary DI / UDI-DI
D0026780201 FDA UDI
FDA Product Code
EHZ FDA UDI
GMDN Term
Dental material cartridge-plunging applicator, two-component, electric FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 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

No

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, two-component, electric

digit® Targeted Delivery System by Dentsply International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentsply International

Sources (1)

  • FDA UDI 9c7a6e8b-8fb2-4179-9d9b-b307f2b7db17 36 fields · synced May 30, 2026