SD NATURALS

GUDID 00855022009292

Blue LED Home Kit

Spa-Dent Inc.

Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit Tooth-bleaching acceleration unit

• Primary Device ID: 00855022009292
• NIH Device Record Key: 26cae0c9-17dd-4a7f-85a7-9e7c28d0c3c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SD NATURALS
• Version Model Number: U128055-R-1
• Company DUNS: 203478896
• Company Name: Spa-Dent Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855022009292 [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: 2020-12-23
• Device Publish Date: 2020-12-15