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

• 07908611211316 - EXTRA-ORAL ELASTIC 8 OZ 1/2" NO MINT FLAVOR: 2025-02-04 EXTRA-ORAL ELASTIC 8 OZ 1/2" NO MINT FLAVOR
• 07908611211323 - EXTRA-ORAL ELASTIC 16 OZ 1/2" NO MINT FLAVOR: 2025-02-04 EXTRA-ORAL ELASTIC 16 OZ 1/2" NO MINT FLAVOR
• 07908611210029 - PROMO KIT ADVANCED ROTH 0.022": 2024-04-24 PROMO KIT ADVANCED ROTH 0.022" - (5X5) + 40 MOLAR TUBES + NITI SE 0.014"
• 07908611210036 - PROMO KIT ADVANCED ROTH 0.022": 2024-04-24 PROMO KIT ADVANCED ROTH 0.022" (5X5) + 40 MOLAR TUBES + NITI SE 0.014 ALX
• 07908611210043 - PROMO KIT ADVANCED MBT 0.022": 2024-04-24 PROMO KIT ADVANCED MBT 0.022" (5X5) + 40 MOLAR TUBES + NITI SE 0.014"
• 07908611210050 - PROMO KIT ADVANCED MBT 0.022": 2024-04-24 PROMO KIT ADVANCED MBT 0.022" (5X5) + 40 MOLAR TUBES + NITI SE 0.014" ALX
• 07908611210067 - PROMO KIT ICERAM-P ROTH 0.022: 2024-04-24 PROMO KIT ICERAM-P ROTH 0.022 – 03 KITS (5X5) + 01 BRACKET REMOVAL PLIER
• 07908611210074 - PROMO KIT ICERAM-P MBT 0.022": 2024-04-24 PROMO KIT ICERAM-P MBT 0.022" – 03 KITS (5X5) + 01 BRACKET REMOVAL PLIER