Piezon

FDA UDI

Class II (US FDA UDI)

by E.M.S. Electro Medical Systems S.A.

Identity

Trade Name: PIEZON FDA UDI
Generic Name: Ultrasonic dental scaling/debridement system FDA UDI
Device Name: Piezon built-in kit FDA UDI
Model / Reference: b FDA UDI
Description: Piezon built-in kit FDA UDI

Identifiers

Catalog Number: FS-321#A/002 FDA UDI
Primary DI / UDI-DI: 07613353087425 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic dental scaling/debridement system

Piezon by E.M.S. Electro Medical Systems S.A. — 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: E.M.S. Electro Medical Systems S.A.

Sources (1)

FDA UDI 611858bc-3458-4d13-97bc-c6ba9ab3f4c2 35 fields · synced May 31, 2026