Roto-Pro Rotosonic

FDA UDI

Class I (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name: ROTO-PRO ROTOSONIC FDA UDI
Generic Name: Rotary dental scaler FDA UDI
Device Name: ROTO-PRO ROTOSONIC SCALERS ROUND, 6 PCS. FDA UDI
Model / Reference: ERP104 FDA UDI
Description: ROTO-PRO ROTOSONIC SCALERS ROUND, 6 PCS. FDA UDI

Identifiers

Catalog Number: ERP104 FDA UDI
Primary DI / UDI-DI: 00841494104542 FDA UDI
FDA Product Code: EJL FDA UDI
GMDN Term: Rotary dental scaler FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3240 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Rotary dental scaler

Roto-Pro Rotosonic by Cynosure, LLC — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Cynosure, LLC

Sources (1)

FDA UDI 97b98de6-6c52-4b34-b7b2-d14973161411 34 fields · synced May 30, 2026