Smilers GOUTPA

GUDID 03770020010040

BIOTECH DENTAL SMILERS

Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer

• Primary Device ID: 03770020010040
• NIH Device Record Key: fa7ec04b-57d5-4d12-869e-c8743bef17c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smilers
• Version Model Number: Passive Appliance
• Catalog Number: GOUTPA
• Company DUNS: 266048588
• Company Name: BIOTECH DENTAL SMILERS
• Device Count: 1
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770020010040 [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