Smilers ALIGN_REPRO

GUDID 03770020010071

BIOTECH DENTAL SMILERS

Orthodontic progressive aligner

• Primary Device ID: 03770020010071
• NIH Device Record Key: 16166c12-b0f3-4b26-82fb-01fa9e8373d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smilers
• Version Model Number: Reproduction Aligner
• Catalog Number: ALIGN_REPRO
• Company DUNS: 266048588
• Company Name: BIOTECH DENTAL SMILERS
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	03770020010071 [Unit of Use]
GS1	03770020010088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212961

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: 2022-04-28
• Device Publish Date: 2022-04-20

On-Brand Devices [Smilers]

• 03770020010071: Reproduction Aligner
• 03770020010057: GOUTC for 2 archs
• 03770020010040: Passive Appliance
• 03770020010026: GOUTP for 2 archs
• 03770020010002: aligners for 2 archs