Z-Activator

FDA UDI

Class I (US FDA UDI)

by Nusmile, Ltd

Identity

Trade Name: Z-Activator FDA UDI
Generic Name: Ultrasonic dental scaling/debridement system FDA UDI
Device Name: Wireless ultrasonic activator. The highest ultrasonic power on the market in its category. FDA UDI
Model / Reference: 6280018 FDA UDI
Description: Wireless ultrasonic activator. The highest ultrasonic power on the market in its category. FDA UDI

Identifiers

Primary DI / UDI-DI: 00810092938699 FDA UDI
FDA Product Code: JET FDA UDI
GMDN Term: Ultrasonic dental scaling/debridement system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ultrasonic dental scaling/debridement system

Z-Activator by Nusmile, Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Nusmile, Ltd

Sources (1)

FDA UDI f103ce4f-2571-4acf-82c9-4443c32474c2 34 fields · synced Jun 8, 2026