Bluewave™ Soft Tissue Diode Laser

FDA UDI

Class II (US FDA UDI)

by Den-Mat Holdings, LLC

Identity

Trade Name: Bluewave™ Soft Tissue Diode Laser FDA UDI
Generic Name: Dental diode laser system FDA UDI
Device Name: Dental diode laser system FDA UDI
Model / Reference: 444000 FDA UDI
Description: Dental diode laser system FDA UDI

Identifiers

Catalog Number: 444000 FDA UDI
Primary DI / UDI-DI: 00359883006587 FDA UDI
510(k) Number: K141838 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Dental 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

Yes

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: Dental diode laser system

Bluewave™ Soft Tissue Diode Laser by Den-Mat Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental diode laser system.

Dental Diode Laser System — Lazon Medical Laser Co., Ltd. · Class II
BLU — Peter Brasseler Holdings, LLC · Class II
Pioneer Elite Perio Tip — CAO GROUP, INC. · Class II
iLase Handpiece — Biolase, Inc. · Class II
STERLING — BENCO DENTAL SUPPLY CO. · Class II
Pioneer Pro Fiber Cartridge — CAO GROUP, INC. · Class II
STERLING — BENCO DENTAL SUPPLY CO. · Class II
Pioneer Elite Standard Fiber Tip — CAO GROUP, INC. · Class II

Cleared under the same submission

K141838 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: Den-Mat Holdings, LLC

Sources (1)

FDA UDI 91e27153-0075-478b-9ed1-f1874573c13c 37 fields · synced Jun 9, 2026