Smile Shapers, Tru-Smile

GUDID 00860002302300

Clear sequential aligner / progressive orthodontic appliance system.

DERBY DENTAL LABORATORY, INC

Orthodontic appliance system, progressive

• 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.