Silfradent S.r.l.

FDA UDI

Class II (US FDA UDI)

by Silfradent Srl

Identity

Trade Name: Silfradent S.r.l. FDA UDI
Generic Name: Ultrasonic dental scaling/debridement system FDA UDI
Device Name: SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performing operations in the field of dental piosthesis and endodontics by means of ultrasound vibrations produced by a piezoelectric transducer. FDA UDI
Model / Reference: SURGYBONE na FDA UDI
Description: SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performing operations in the field of dental piosthesis and endodontics by means of ultrasound vibrations produced by a piezoelectric transducer. FDA UDI

Identifiers

Primary DI / UDI-DI: 08056093310016 FDA UDI
510(k) Number: K083569 FDA UDI
FDA Product Code: DZI FDA UDI
GMDN Term: Ultrasonic dental scaling/debridement system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4120 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

Category: Ultrasonic dental scaling/debridement system

Silfradent S.r.l. by Silfradent Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K083569 also covers:

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: Silfradent Srl

Sources (1)

FDA UDI cf24226f-7a89-4c7a-a7de-78c92712780e 35 fields · synced May 30, 2026