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A-dec

FDA UDI

Class II (US FDA UDI)

by A-Dec, Inc.

Identity

Trade Name
A-dec FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece FDA UDI
Device Name
Kit, Newtron CAN,Ctrl Module, Short Tubing, OTC FDA UDI
Model / Reference
No Version or Model Number FDA UDI
Description
Kit, Newtron CAN,Ctrl Module, Short Tubing, OTC FDA UDI

Identifiers

Catalog Number
54.1042.00 FDA UDI
Primary DI / UDI-DI
10194665008321 FDA UDI
510(k) Number
K233922 FDA UDI
FDA Product Code
ELC FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4850 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

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic dental scaling/debridement system handpiece

A-dec by A-Dec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic dental scaling/debridement system handpiece.

Cleared under the same submission

K233922 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
A-Dec, Inc.

Sources (1)

  • FDA UDI c2bf883d-d319-48e7-ab24-10d0e75ca268 35 fields · synced May 30, 2026