Erkoflex-95

GUDID ERKO5893403

Erkoflex-95, 4.00 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

• Primary Device ID: ERKO5893403
• NIH Device Record Key: 9e1424f4-1562-4693-a140-924c6c1b533f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erkoflex-95
• Version Model Number: 589340
• 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	ERKO5893403 [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 [Erkoflex-95]

• ERKO5893403: Erkoflex-95, 4.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5893253: Erkoflex-95, 2.50 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5893153: Erkoflex-95, 1.50 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5892251: Erkoflex-95, 2.50 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5859251: Erkoflex-95, 2.50 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication o
• ERKO5854152: Erkoflex-95, 1.50 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication o