Dento-Surg

FDA UDI

Class II (US FDA UDI)

by Cynosure, LLC

Identity

Trade Name: Dento-Surg FDA UDI
Generic Name: Electrosurgical system generator FDA UDI
Device Name: DENTO-SURG 90 F.F.P. 110 VOLTS FDA UDI
Model / Reference: DEN90110 FDA UDI
Description: DENTO-SURG 90 F.F.P. 110 VOLTS FDA UDI

Identifiers

Catalog Number: DEN90110 FDA UDI
Primary DI / UDI-DI: 00841494102517 FDA UDI
510(k) Number: K955176 FDA UDI
FDA Product Code: EKZ FDA UDI
GMDN Term: Electrosurgical system generator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4920 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical system generator

Dento-Surg by Cynosure, LLC — 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: Cynosure, LLC

Sources (1)

FDA UDI 781a3dcd-0ccf-4c58-9a4e-6712cf63cf28 35 fields · synced Jun 7, 2026