Tru-Smile

GUDID 00860002302331

Clear sequential aligner (final retainer) / progressive orthodontic appliance system.

DERBY DENTAL LABORATORY, INC

Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer

• Primary Device ID: 00860002302331
• NIH Device Record Key: 2b943660-1c73-45fa-8c6f-05e580e8ce08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tru-Smile
• Version Model Number: TSR
• Company DUNS: 603741349
• Company Name: DERBY DENTAL LABORATORY, INC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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
GS1	00860002302331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173785

FDA Product Code

• DYT: Maintainer, Space Preformed, Orthodontic

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: 2020-04-23
• Device Publish Date: 2020-04-15

On-Brand Devices [Tru-Smile]

• 00860002302348: Clear sequential aligner / progressive orthodontic appliance system.
• 00860002302331: Clear sequential aligner (final retainer) / progressive orthodontic appliance system.