Erkoloc-pro

GUDID ERKO5955401

Erkoloc-pro, 4.00 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Erkodent Erich Kopp GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: ERKO5955401
• NIH Device Record Key: 7f02dc6f-dd8e-4752-8c4d-2c880248b197
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erkoloc-pro
• Version Model Number: 595540
• 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 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ERKO5955401 [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]

• ERKO5955501: Erkoloc-pro, 5.00 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5955401: Erkoloc-pro, 4.00 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5955301: Erkoloc-pro, 3.00 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5955201: Erkoloc-pro, 2.00 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5955131: Erkoloc-pro, 1.30 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5954302: Erkoloc-pro, 3.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5954202: Erkoloc-pro, 2.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5954132: Erkoloc-pro, 1.30 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5954102: Erkoloc-pro, 1.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5953503: Erkoloc-pro, 5.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5953403: Erkoloc-pro, 4.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5953303: Erkoloc-pro, 3.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5953203: Erkoloc-pro, 2.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5953133: Erkoloc-pro, 1.30 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5951501: Erkoloc-pro, 5.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5951401: Erkoloc-pro, 4.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o