Cavitron®

FDA UDI

Class II (US FDA UDI)

by Dentsply Professional

Identity

Trade Name: Cavitron® FDA UDI
Generic Name: Ultrasonic dental scaling/debridement system FDA UDI
Device Name: Cavitron® prophy-jet® Package. Also contains: Cavitron Prophy-Jet Air Polishing System, JET-Mate® Sterilizable Detachable Handpieces, JET Air Polishing Inserts, Prophy-JET® Sodium Bicarbonate Powder 13 Oz. Bottle, JET-Fresh® Aluminum Trihydroxide Prophy Powder 13 Oz. Bottle, Cavitron Care Maintenance Plan Registration Information. FDA UDI
Model / Reference: 8161427 FDA UDI
Description: Cavitron® prophy-jet® Package. Also contains: Cavitron Prophy-Jet Air Polishing System, JET-Mate® Sterilizable Detachable Handpieces, JET Air Polishing Inserts, Prophy-JET® Sodium Bicarbonate Powder 13 Oz. Bottle, JET-Fresh® Aluminum Trihydroxide Prophy Powder 13 Oz. Bottle, Cavitron Care Maintenance Plan Registration Information. FDA UDI

Identifiers

Primary DI / UDI-DI: D00381614271 FDA UDI
FDA Product Code: ELC FDA UDI
GMDN Term: Ultrasonic dental scaling/debridement system 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

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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic dental scaling/debridement system

Cavitron® by Dentsply Professional — 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: Dentsply Professional

Sources (1)

FDA UDI 09e1751f-df72-440a-8034-c53795376be3 35 fields · synced May 30, 2026