Jetsonic 2000m Handpiece

FDA UDI

Class II (US FDA UDI)

by Deldent Ltd.

Identity

Trade Name: JETSONIC 2000M HANDPIECE FDA UDI
Generic Name: Ultrasonic dental scaling/debridement system FDA UDI
Device Name: Dental Scaler Handpiece FDA UDI
Model / Reference: 533002 FDA UDI
Description: Dental Scaler Handpiece FDA UDI

Identifiers

Catalog Number: 533002 FDA UDI
Primary DI / UDI-DI: 07290016281996 FDA UDI
510(k) Number: K014245 FDA UDI
FDA Product Code: KOJ FDA UDI
GMDN Term: Ultrasonic dental scaling/debridement system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6080 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic dental scaling/debridement system

Jetsonic 2000m Handpiece by Deldent Ltd. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Deldent Ltd.

Sources (1)

FDA UDI bda7f1f0-6a90-40bf-a326-d5ee029eb940 35 fields · synced Jun 6, 2026