Ledx-Pro

FDA UDI

Class II (US FDA UDI)

by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda

Identity

Trade Name: LEDX-PRO FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION FDA UDI
Model / Reference: 90.10.2403 FDA UDI
Description: ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION FDA UDI

Identifiers

Catalog Number: 90.10.2403 FDA UDI
Primary DI / UDI-DI: 07908611204455 FDA UDI
510(k) Number: K131042 FDA UDI
FDA Product Code: EBZ FDA UDI
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6070 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental/surgical polymerization lamp

Ledx-Pro by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Dental/surgical polymerization lamp.

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VALO — ULTRADENT PRODUCTS, INC. · Class II
WOODPECKER — Guilin Woodpecker Medical Instrument Co., Ltd. · Class II
VALO — ULTRADENT PRODUCTS, INC. · Class II
Coltolux — Coltene/Whaledent Inc. · Class II
Ascent PX Charging Station — CAO GROUP, INC. · Class II

Cleared under the same submission

K131042 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: Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda

Sources (1)

FDA UDI 7228d683-2426-4696-8c0d-52a46470cf66 35 fields · synced May 31, 2026