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SleeperOne 5 SO_5C

by Dentalhitec

SleeperOne 5 SO_5C (SO-5C) is a Class II device made by Dentalhitec, listed in FDA GUDID since 22 Aug 2023 (UDI-DI 03760349803331), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760349803331 UDI-DI Date22 Aug 2023ListedStatusListed 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  • Withdrawn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
SleeperOne 5
Generic name
Dental anaesthesia electronic injector
Model / Ref / Catalog
SO_5C, SO-5C
Primary DI / UDI-DI
03760349803331
FDA product code
EJI
GMDN term
Dental anaesthesia electronic injector
Device class
Class II
Regulation number
872.6770
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental computer assisted anaesthesia injection unit

Similar devices

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

Other devices from Dentalhitec

See all devices from Dentalhitec →

Properties

  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)