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Calaject 2118

by Rønvig Dental Manufacturing A/S

Calaject 2118 is a Class II device made by Rønvig Dental Manufacturing A/S, listed in FDA GUDID since 28 Sep 2017 (UDI-DI 05713513000942), 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 Number05713513000942 UDI-DI Date28 Sep 2017ListedStatusListed 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  • Withdrawn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
Calaject
Generic name
Dental anaesthesia electronic injector
Model / reference
2118
Primary DI / UDI-DI
05713513000942
FDA product code
EJI
GMDN term
Dental anaesthesia electronic injector
Device class
Class II
Regulation number
872.6770
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code EJI (Syringe, Cartridge).

Other devices from Rønvig Dental Manufacturing A/S

See all devices from Rønvig Dental Manufacturing A/S →

Properties

  • Sterilise before use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)