LEDX-PRO 90.10.2403

GUDID 07908611204455

ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Dental/surgical polymerization lamp

• Primary Device ID: 07908611204455
• NIH Device Record Key: 7228d683-2426-4696-8c0d-52a46470cf66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEDX-PRO
• Version Model Number: 90.10.2403
• Catalog Number: 90.10.2403
• Company DUNS: 898330003
• Company Name: ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07908611204455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131042

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-13
• Device Publish Date: 2023-04-05

Devices Manufactured by ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

• 07908611211507 - METAL BRACKETS MAGNUM ROTH 0,022" – 100 SETS: 2025-09-05 METAL BRACKETS MAGNUM ROTH 0,022" – 100 SETS
• 07908611210333 - ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULAR: 2025-04-15 1 SET ICERAM-P MBT 0.022 1 PAIR OF ESTHETIC ARCHWIRES 1 PEARL BLUE MODULAR
• 07908611210340 - ICERAM-P MBT 0.022 KIT – 5 SETS + 1 FREE MIXED ORTHODONTIC MANNEQUIN: 2025-04-15 ICERAM-P MBT 0.022 5 SETS 1 FREE MIXED ORTHODONTIC MANNEQUIM
• 07908611211163 - PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR: 2025-04-15 PREMIUM ELITE KIT ROTH 0.022 – 1 SET 4 TUBES 1 PAIR OF ARCHEWIRE 1 MODULAR LIGATURE
• 07908611211170 - PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR: 2025-04-15 PREMIUM ELITE KIT MBT 0.022 1 SET 4 TUBES 1 PAIR OF ARCHWIRES 1 MODULAR LIGATURE
• 07908611211200 - BUTTON WITH HOOK MJANSON: 2025-04-15 BUTTON WITH HOOK BONDING MJANSON
• 07908611211217 - ORTHODONTIC POWER ARM BUTTON FOR BONDING MJANSON – DISK HOOK: 2025-04-15 ORTHODONTIC POWER ARM BUTTON FOR BONDING MJANSON – DISK HOOK
• 07908611211224 - ORTHODONTIC POWER ARM BUTTON FOR CRIMPING MJANSON – DISK HOOK: 2025-04-15 ORTHODONTIC POWER ARM BUTTON FOR CRIMPING MJANSON – DISK HOOK