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SleeperOne 5

FDA UDI

Class II (US FDA UDI)

by Dentalhitec

Identity

Trade Name
SleeperOne 5 FDA UDI
Generic Name
Dental computer assisted anaesthesia injection unit FDA UDI
Device Name
1 SleeperOne 5 handpiece and control box 1 wireless pedal 1 battery charger 1 power supply, 10 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521) FDA UDI
Model / Reference
SO_5C FDA UDI
Description
1 SleeperOne 5 handpiece and control box 1 wireless pedal 1 battery charger 1 power supply, 10 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521) FDA UDI

Identifiers

Catalog Number
SO-5C FDA UDI
Primary DI / UDI-DI
03760349803331 FDA UDI
FDA Product Code
EJI FDA UDI
GMDN Term
Dental computer assisted anaesthesia injection unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6770 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental computer assisted anaesthesia injection unit

SleeperOne 5 by Dentalhitec — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental computer assisted anaesthesia injection unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentalhitec

Sources (1)

  • FDA UDI 47cb199b-b679-45a4-84ff-dd04116f3eb6 34 fields · synced May 31, 2026