LEDEX

GUDID 04719873921577

WL-070+ Red (US) (ORTHO Version)

DENTMATE TECHNOLOGY CO., LTD.

Dental/surgical polymerization lamp

• Primary Device ID: 04719873921577
• NIH Device Record Key: b8916c23-c4c0-4e05-8ad0-d957453b2e45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEDEX
• Version Model Number: WL-070+ (ORTHO)
• Company DUNS: 656134660
• Company Name: DENTMATE TECHNOLOGY CO., LTD.
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	04719873921577 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163605

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: 2019-07-24
• Device Publish Date: 2019-07-16

On-Brand Devices [LEDEX]

• 04719873921966: WL-070+ Purple (US) (Practicon) (ORTHO Version)
• 04719873921959: WL-070+ Red (US) (Practicon) (ORTHO Version)
• 04719873921942: WL-070+ Green (US) (Practicon) (ORTHO Version)
• 04719873921935: WL-070+ Blue (US) (Practicon) (ORTHO Version)
• 04719873921928: WL-070+ Orange (US) (Practicon) (ORTHO Version)
• 04719873921911: WL-070+ Black (US) (Practicon) (ORTHO Version)
• 04719873921904: WL-070+ White (US) (Practicon) (ORTHO Version)
• 04719873921584: WL-070+ Purple (US) (ORTHO Version)
• 04719873921577: WL-070+ Red (US) (ORTHO Version)
• 04719873921560: WL-070+ Green (US) (ORTHO Version)
• 04719873921553: WL-070+ Blue (US) (ORTHO Version)
• 04719873921546: WL-070+ Orange (US) (ORTHO Version)
• 04719873921539: WL-070+ Black (US) (ORTHO Version)
• 04719873921263: WL-070+ White (US) (ORTHO Version)
• 04719873920730: WL-070+ Purple (US)
• 04719873920723: WL-070+ Red (US)
• 04719873920716: WL-070+ Green (US)
• 04719873920709: WL-070+ Blue (US)
• 04719873920693: WL-070+ Orange (US)
• 04719873920686: WL-070+ Black (US)
• 04719873920679: WL-070+ White (US)
• 04719873920167: WL-070 Yellow+Black (US)
• 04719873920150: WL-070 Yellow+Black (US)
• 04719873920143: WL-070 Pink (US)
• 04719873920136: WL-070 Yellow (US)
• 04719873920129: WL-070 Green (US)
• 04719873920112: WL-070 Blue (US)
• 04719873920105: WL-070 Orange (US)
• 04719873920099: WL-070 Black (US)
• 04719873920082: WL-070 White (US)
• 04719873922444: WL-120(Dentmate)
• 04719873922215: WL-120 (ALLURE)