Erkoloc-pro pink

GUDID ERKO5983403

Erkoloc-pro pink, 4.00 mm, Ø 120 mm. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Erkodent Erich Kopp GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: ERKO5983403
• NIH Device Record Key: 7448aa67-4a26-43ae-8c23-9f3e19fab065
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erkoloc-pro pink
• Version Model Number: 598340
• Company DUNS: 317654200
• Company Name: Erkodent Erich Kopp GmbH
• 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: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 96 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 96 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 96 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 96 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 96 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 96 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 96 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 96 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 96 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ERKO5983403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200125

FDA Product Code

• MQC: Mouthguard, Prescription

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: 2021-09-02
• Device Publish Date: 2021-08-25

On-Brand Devices [Erkoloc-pro pink]

• ERKO5983403: Erkoloc-pro pink, 4.00 mm, Ø 120 mm. Thermoforming sheet material for the fabrication of orthod
• ERKO5975201: Erkoloc-pro pink, 2.00 mm, Ø 125 mm. Thermoforming sheet material for the fabrication of orthod
• ERKO5969502: Erkoloc-pro pink, 5.00 mm, Ø 120 mm. Thermoforming sheet material for the fabrication of orthod
• ERKO5969402: Erkoloc-pro pink, 4.00 mm, Ø 120 mm. Thermoforming sheet material for the fabrication of orthod
• ERKO5969302: Erkoloc-pro pink, 3.00 mm, Ø 120 mm. Thermoforming sheet material for the fabrication of orthod
• ERKO5969202: Erkoloc-pro pink, 2.00 mm, Ø 120 mm. Thermoforming sheet material for the fabrication of orthod