Smile Shapers, Tru-Smile

GUDID 00860002302300

Clear sequential aligner / progressive orthodontic appliance system.

DERBY DENTAL LABORATORY, INC

Orthodontic appliance system, progressive Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner Orthodontic progressive aligner

• Primary Device ID: 00860002302300
• NIH Device Record Key: cdce462c-02a7-49e7-b71d-0d71bf2663ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smile Shapers, Tru-Smile
• Version Model Number: 01
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002302300 [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: 2020-01-21
• Device Publish Date: 2020-01-13

Devices Manufactured by DERBY DENTAL LABORATORY, INC

• 00860002302355 - Phase Ortho: 2020-05-11 Clear sequential aligner / progressive orthodontic appliance system.
• 00860002302362 - Phase Ortho: 2020-05-11 Clear sequential aligner (final retainer) / progressive orthodontic appliance system.
• 00860002302317 - Smile Shapers: 2020-04-23 Clear sequential aligner / progressive orthodontic appliance system.
• 00860002302324 - Smile Shapers: 2020-04-23 Clear sequential aligner (final retainer) / progressive orthodontic appliance system.
• 00860002302331 - Tru-Smile: 2020-04-23 Clear sequential aligner (final retainer) / progressive orthodontic appliance system.
• 00860002302348 - Tru-Smile: 2020-04-23 Clear sequential aligner / progressive orthodontic appliance system.
• 00860002302300 - Smile Shapers, Tru-Smile: 2020-01-21Clear sequential aligner / progressive orthodontic appliance system.
• 00860002302300 - Smile Shapers, Tru-Smile: 2020-01-21 Clear sequential aligner / progressive orthodontic appliance system.