Primo Dental Laser

FDA UDI

Class II (US FDA UDI)

by Medency Srl

Identity

Trade Name: Primo Dental Laser FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: Max power: 3W Wavelength: 450nm The model Primo Blue of the family of medical devices "Primo Dental Laser" is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It’s a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts. FDA UDI
Model / Reference: Primo Blue FDA UDI
Description: Max power: 3W Wavelength: 450nm The model Primo Blue of the family of medical devices "Primo Dental Laser" is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It’s a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts. FDA UDI

Identifiers

Catalog Number: MD.PRIMO.E.06.02.DEN FDA UDI
Primary DI / UDI-DI: 08059340290048 FDA UDI
510(k) Number: K232222 FDA UDI
FDA Product Code: GEX FDA UDI
NVK FDA UDI
GMDN Term: General/multiple surgical diode laser system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: General/multiple surgical diode laser system

Primo Dental Laser by Medency Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K232222 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: Medency Srl

Sources (1)

FDA UDI 973e6d2e-7022-4200-b760-5b97ecfd7e6a 35 fields · synced May 30, 2026