Erkoloc-pro

GUDID ERKO5951501

Erkoloc-pro, 5.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Erkodent Erich Kopp GmbH

Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic

• Primary Device ID: ERKO5951501
• NIH Device Record Key: 58ba3bc7-e44c-4620-8978-330e82a89768
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erkoloc-pro
• Version Model Number: 595150
• 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	ERKO5951501 [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