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Sirosonic

FDA UDI

Class II (US FDA UDI)

by Sirona Dental Systems GmbH

Identity

Trade Name
SIROSONIC FDA UDI
Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI
Device Name
Set SIROSONIC L (2 pc.) FDA UDI
Model / Reference
6562834 FDA UDI
Description
Set SIROSONIC L (2 pc.) FDA UDI

Identifiers

Primary DI / UDI-DI
E27665628342 FDA UDI
510(k) Number
K033640 FDA UDI
K150909 FDA UDI
FDA Product Code
ELC FDA UDI
EIA FDA UDI
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, periodontal FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4850 FDA UDI
872.6640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Sirosonic by Sirona Dental Systems GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasonic dental scaling/debridement system handpiece tip, periodontal.

Cleared under the same submission

K033640 also covers:

K150909 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sirona Dental Systems GmbH

Sources (1)

  • FDA UDI 2fc7f18c-09c0-4786-ae87-5c194e6e16d7 35 fields · synced May 30, 2026