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COMPO-JECT 2.0 black handle 20006

by Rønvig Dental Manufacturing A/S

COMPO-JECT 2.0 black handle 20006 is a Class I device made by Rønvig Dental Manufacturing A/S, listed in FDA GUDID since 14 Apr 2026 (UDI-DI 05713513001307), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05713513001307 UDI-DI Date14 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
COMPO-JECT 2.0 black handle
Generic name
Dental material application tool, reusable
Model / reference
20006
Primary DI / UDI-DI
05713513001307
FDA product code
EJB
GMDN term
Dental material application tool, reusable
Device class
Class I
Regulation number
872.4565
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code EJB (Handle, Instrument, Dental).

Other devices from Rønvig Dental Manufacturing A/S

See all devices from Rønvig Dental Manufacturing A/S →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)