Smile Shapers

GUDID 00860002302317

Clear sequential aligner / progressive orthodontic appliance system.

DERBY DENTAL LABORATORY, INC

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• Primary Device ID: 00860002302317
• NIH Device Record Key: 12424f48-3bb4-4c2d-9220-439f2a2ac43c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smile Shapers
• Version Model Number: SSCA
• 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	00860002302317 [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 [Smile Shapers]

• 00860002302324: Clear sequential aligner (final retainer) / progressive orthodontic appliance system.
• 00860002302317: Clear sequential aligner / progressive orthodontic appliance system.