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Device Explorer · FDA GUDID · GMDN 35775

Dental/surgical polymerization lamp

A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a ligh

US‑registered devices618in commercial distribution
Companies56labelers on GUDID
Single‑use18%of device records
Sterile0%labelled sterile
Prescription69%Rx‑only share
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Share of device records

Ultradent Products, Inc.9415%
Guilin Woodpecker Medical Instrument Co., Ltd.5910%
Coltene/Whaledent Inc478%
Satelec366%
Dentmate Technology Co., Ltd.346%
Ivoclar Vivadent Aktiengesellschaft264%
Den-Mat Holdings, Llc264%
Kerr Corporation203%

Top labelers

CompanyDevicesShare
Ultradent Products, Inc.9415%
Guilin Woodpecker Medical Instrument Co., Ltd.5910%
Coltene/Whaledent Inc478%
Satelec366%
Dentmate Technology Co., Ltd.346%
Ivoclar Vivadent Aktiengesellschaft264%
Den-Mat Holdings, Llc264%
Kerr Corporation203%
Benco Dental Supply Co.203%
Apoza Enterprise Co., Ltd.193%
Garrison Dental Solutions, L.L.C.163%
Diadent Group International163%

Company = labeler of record on GUDID. 56 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

JAS ActivatorCICADACOXOEighteethREFINEDTEwoodpeckerWOODPECKERWOODPECKER,DTEDBARTAKulzerAPOZALEDEXBlueLEXMECTRON

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

FDA product codes

CodeNameDevices
EBZActivator, Ultraviolet, For Polymerization425
EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION197
EAQDetector, Ultraviolet37
PEQAccessories To Examination Light37
ELCScaler, Ultrasonic29
QNFLaser Activator For Polymerization7

GMDN & GCC registration

  • GMDN code 35775 · non‑implantable
  • Single‑use 18% · sterile 0% · Rx‑only 69% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 11Lumen/Inner Diameter (Millimeter) · 6Outer Diameter (Centimeter) · 2Length (Centimeter) · 2

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

How many dental/surgical polymerization lamp products are registered in the US?

618 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental/surgical polymerization lamp", from 56 companies. The largest labeler is Ultradent Products, Inc. with 15% of records.

Which FDA product codes apply?

EBZ (Activator, Ultraviolet, For Polymerization), EBZ (ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION), EAQ (Detector, Ultraviolet), PEQ (Accessories To Examination Light)

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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