Froggymouth FM2017-01

GUDID 03770020010163

BIOTECH DENTAL SMILERS

Orthodontic retainer

• Primary Device ID: 03770020010163
• NIH Device Record Key: 52bbcf25-5e96-4600-8a34-a8bbffdb175b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Froggymouth
• Version Model Number: Froggymouth size S
• Catalog Number: FM2017-01
• Company DUNS: 266048588
• Company Name: BIOTECH DENTAL SMILERS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Dimensions

• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter
• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter
• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter
• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter
• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter
• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter
• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter
• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter
• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter
• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter
• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter
• Length: 36 Millimeter
• Width: 21 Millimeter
• Height: 30 Millimeter
• Area/Surface Area: 4442 Square millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from heat, sunlight, and sources of radiation.

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770020010163 [Primary]

FDA Product Code

• KMY: Positioner, Tooth, Preformed

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: 2026-03-25
• Device Publish Date: 2026-03-17

On-Brand Devices [Froggymouth]

• 03770020010187: Froggymouth size L
• 03770020010170: Froggymouth size M
• 03770020010163: Froggymouth size S