Vivastyle 756342

GUDID D7077563420

VivaStyle Whitening LED Kit

IVOCLAR VIVADENT, INC.

Tooth-bleaching acceleration unit

• Primary Device ID: D7077563420
• NIH Device Record Key: f077ddf5-f1a0-4d73-975b-2988b8ec44fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivastyle
• Version Model Number: 756342
• Catalog Number: 756342
• Company DUNS: 176935203
• Company Name: IVOCLAR VIVADENT, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
HIBCC	D7077563420 [Direct Marking]
HIBCC	D7077563421 [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: 2023-11-10
• Device Publish Date: 2023-11-02

Devices Manufactured by IVOCLAR VIVADENT, INC.

• D707NA60501410 - Valiant: 2023-12-21
• D7076464481 - Virtual XD: 2023-11-17 Virtual XD 380 Refill Heavy Body F 2X380
• D7076464491 - Virtual XD: 2023-11-17 Virtual XD 380 Refill Heavy Body R 2X380
• D7076464591 - Virtual XD: 2023-11-17 Virtual XD Refill Heavy Body F 2X50 ml
• D7076464601 - Virtual XD: 2023-11-17 Virtual XD Refill Heavy Body R 2X50 ml
• D7076464611 - Virtual XD: 2023-11-17 Virtual XD Refill Light F 2X50 ml
• D7076464621 - Virtual XD: 2023-11-17 Virtual XD Refill Light R 2X50 ml
• D7076464671 - Virtual XD: 2023-11-17 Virtual XD Refill Extra Light F 2X50 ml