e-light B-US 230020149

GUDID 07898616351417

Heat source for bleaching teeth

DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA

Tooth-bleaching acceleration unit

• Primary Device ID: 07898616351417
• NIH Device Record Key: 97f13455-0258-4b6e-abef-9781f83fe64d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-light B-US
• Version Model Number: 230020149
• Catalog Number: 230020149
• Company DUNS: 904563269
• Company Name: DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	07898616351417 [Primary]

FDA Product Code

• EEG: Heat Source For Bleaching Teeth

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: 2025-03-13
• Device Publish Date: 2025-03-05

Devices Manufactured by DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDA

• 07898616351431 - OstomyGel: 2025-05-06 Ostomy accessory
• 07898616351400 - e-light I-US: 2025-03-13 Laser system for therapy
• 07898616351417 - e-light B-US: 2025-03-13Heat source for bleaching teeth
• 07898616351417 - e-light B-US: 2025-03-13 Heat source for bleaching teeth
• 07898616351424 - e-light V-US: 2025-03-13 Heat source for bleaching teeth
• 07898616351127 - Therapy EC (FDA): 2025-01-29 Laser system for therapy
• 07898616351134 - Therapy XT (FDA): 2025-01-29 Laser system for therapy