Tru-Smile

GUDID 00860002302348

Clear sequential aligner / progressive orthodontic appliance system.

DERBY DENTAL LABORATORY, INC

Orthodontic appliance system, progressive

• Primary Device ID: 00860002302348
• NIH Device Record Key: ba4da5e9-89d1-4c31-991a-167b9a11a967
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tru-Smile
• Version Model Number: TSCA
• 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	00860002302348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173785

FDA Product Code

• NXC: Aligner, Sequential

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.