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Compo-Ject

FDA UDI

Class I (US FDA UDI)

by Rønvig Dental Manufacturing A/S

Identity

Trade Name
COMPO-JECT FDA UDI
Generic Name
Dental material application tool, reusable FDA UDI
Device Name
Composite Applicator for delivery of dental materials in pre-filled unit-dose tips for direct oral application. FDA UDI
Model / Reference
20003 FDA UDI
Description
Composite Applicator for delivery of dental materials in pre-filled unit-dose tips for direct oral application. FDA UDI

Identifiers

Primary DI / UDI-DI
05713513000119 FDA UDI
FDA Product Code
EJB FDA UDI
GMDN Term
Dental material application tool, reusable 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

No

FDA UDI

Over-the-Counter

Yes

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 application tool, reusable

Compo-Ject by Rønvig Dental Manufacturing A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental material application tool, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rønvig Dental Manufacturing A/S

Sources (1)

  • FDA UDI 004fe0b6-f92a-447c-a89e-81c2a4090dee 33 fields · synced Jun 6, 2026