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Device Explorer · FDA GUDID · GMDN 60340

Dental diode laser system

A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue s

US‑registered devices236in commercial distribution
Companies15labelers on GUDID
Single‑use32%of device records
Sterile5%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Cao Group, Inc.6929%
Den-Mat Holdings, Llc4318%
Azena Medical, Llc3515%
Biolase, Inc.3013%
Lazon Medical Laser Co., Ltd.167%
Sirona Dental Systems Gmbh83%
Peter Brasseler Holdings, Llc83%
Benco Dental Supply Co.83%

Top labelers

CompanyDevicesShare
Cao Group, Inc.6929%
Den-Mat Holdings, Llc4318%
Azena Medical, Llc3515%
Biolase, Inc.3013%
Lazon Medical Laser Co., Ltd.167%
Sirona Dental Systems Gmbh83%
Peter Brasseler Holdings, Llc83%
Benco Dental Supply Co.83%
Gigaalaser Company Ltd.42%
Guilin Woodpecker Medical Instrument Co., Ltd.42%
Lambda Spa42%
Hulaser, Inc.31%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Bluewave™ Soft Tissue Diode LaserGIGAASWOTDental Diode Laser SystemWOODPECKERDTEEasyTip 320 Pack 25EasyTip Endo Pack 25SIROLaser Blue USASIROLaser Advance+ USASiroLaserEasyTip 200 Pack 25BLUPicasso Pro Pre-initiated Laser Tip, Variety PacPicasso Pro Disposable Therapy Tip, CurvedPicasso Pro Disposable Therapy Tip, Straight

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
GEXPowered Laser Surgical Instrument251
NVKLaser, Dental, Soft Tissue47
GEXPowered laser surgical instrument39
ILYLamp, Infrared, Therapeutic Heating36
ILYLamp, infrared, therapeutic heating26
EEGHeat Source For Bleaching Teeth1

GMDN & GCC registration

  • GMDN code 60340 · non‑implantable
  • Single‑use 32% · sterile 5% · Rx‑only 85% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 31Outer Diameter (Micrometer) · 28Angle (degree) · 6Width (Micrometer) · 4Length (Feet) · 2Length (Micrometer) · 2

Use these as the dimensions to specify in a tender line.

How many dental diode laser system products are registered in the US?

236 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental diode laser system", from 15 companies. The largest labeler is Cao Group, Inc. with 29% of records.

Which FDA product codes apply?

GEX (Powered Laser Surgical Instrument), NVK (Laser, Dental, Soft Tissue), GEX (Powered laser surgical instrument), ILY (Lamp, Infrared, Therapeutic Heating)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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