Erkoflex

GUDID ERKO5842512

Erkoflex, 4.00 mm, Ø 120 mm, maroon. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Erkodent Erich Kopp GmbH

Dental appliance fabrication material, thermoplastic

• Primary Device ID: ERKO5842512
• NIH Device Record Key: d43134a0-c397-48da-8cba-1cbac903acf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Erkoflex
• Version Model Number: 584251
• 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	ERKO5842512 [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: 2021-09-03
• Device Publish Date: 2021-08-26

On-Brand Devices [Erkoflex]

• ERKO5842582: Erkoflex, 4.00 mm, Ø 120 mm, yolk yellow. Thermoforming sheet material for the fabrication of o
• ERKO5842572: Erkoflex, 4.00 mm, Ø 120 mm, orange. Thermoforming sheet material for the fabrication of orthod
• ERKO5842562: Erkoflex, 4.00 mm, Ø 120 mm, silver. Thermoforming sheet material for the fabrication of orthod
• ERKO5842552: Erkoflex, 4.00 mm, Ø 120 mm, gold. Thermoforming sheet material for the fabrication of orthodon
• ERKO5842542: Erkoflex, 4.00 mm, Ø 120 mm, deep black. Thermoforming sheet material for the fabrication of or
• ERKO5842532: Erkoflex, 4.00 mm, Ø 120 mm, pure white. Thermoforming sheet material for the fabrication of or
• ERKO5842522: Erkoflex, 4.00 mm, Ø 120 mm, deep green. Thermoforming sheet material for the fabrication of or
• ERKO5842512: Erkoflex, 4.00 mm, Ø 120 mm, maroon. Thermoforming sheet material for the fabrication of orthod
• ERKO5842482: Erkoflex, 4.00 mm, Ø 120 mm, light blue. Thermoforming sheet material for the fabrication of or
• ERKO5842472: Erkoflex, 4.0 mm, Ø 120 mm, night blue. Thermoforming sheet material for the fabrication of ort
• ERKO5842462: Erkoflex, 4.00 mm, Ø 120 mm, deep red. Thermoforming sheet material for the fabrication of orth
• ERKO5842452: Erkoflex, 4.00 mm, Ø 120 mm, bright pink. Thermoforming sheet material for the fabrication of o
• ERKO5842442: Erkoflex, 4.00 mm, Ø 120 mm, bright green. Thermoforming sheet material for the fabrication of
• ERKO5842432: Erkoflex, 4.00 mm, Ø 120 mm, bright blue. Thermoforming sheet material for the fabrication of o
• ERKO5842422: Erkoflex, 4.00 mm, Ø 120 mm, bright yellow. Thermoforming sheet material for the fabrication of
• ERKO5842412: Erkoflex, 4.00 mm, Ø 120 mm, bright red. Thermoforming sheet material for the fabrication of or
• ERKO5842372: Erkoflex, 2.00 mm, Ø 120 mm, orange. Thermoforming sheet material for the fabrication of orthod
• ERKO5842362: Erkoflex, 2.00 mm, Ø 120 mm, silver. Thermoforming sheet material for the fabrication of orthod
• ERKO5842352: Erkoflex, 2.00 mm, Ø 120 mm, gold. Thermoforming sheet material for the fabrication of orthodon
• ERKO5842342: Erkoflex, 2.00 mm, Ø 120 mm, deep black. Thermoforming sheet material for the fabrication of or
• ERKO5842332: Erkoflex, 2.00 mm, Ø 120 mm, pure white. Thermoforming sheet material for the fabrication of or
• ERKO5842322: Erkoflex, 2.00 mm, Ø 120 mm, deep green. Thermoforming sheet material for the fabrication of or
• ERKO5842312: Erkoflex, 2.00 mm, Ø 120 mm, maroon. Thermoforming sheet material for the fabrication of orthod
• ERKO5842282: Erkoflex, 2.00 mm, Ø 120 mm, light blue. Thermoforming sheet material for the fabrication of or
• ERKO5842272: Erkoflex, 2.00 mm, Ø 120 mm, night blue. Thermoforming sheet material for the fabrication of or
• ERKO5842262: Erkoflex, 2.00 mm, Ø 120 mm, deep red. Thermoforming sheet material for the fabrication of orth
• ERKO5842252: Erkoflex, 2.00 mm, Ø 120 mm, bright pink. Thermoforming sheet material for the fabrication of o
• ERKO5842242: Erkoflex, 2.00 mm, Ø 120 mm, bright green. Thermoforming sheet material for the fabrication of
• ERKO5842232: Erkoflex, 2.00 mm, Ø 120 mm, bright blue. Thermoforming sheet material for the fabrication of o
• ERKO5842222: Erkoflex, 2.00 mm, Ø 120 mm, bright yellow. Thermoforming sheet material for the fabrication of
• ERKO5842212: Erkoflex, 2.00 mm, Ø 120 mm, bright red. Thermoforming sheet material for the fabrication of or
• ERKO5832403: Erkoflex, 4.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of o
• ERKO5832303: Erkoflex, 3.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of o
• ERKO5832203: Erkoflex, 2.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of o
• ERKO5832153: Erkoflex, 1.50 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of o
• ERKO5832103: Erkoflex, 1.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of o
• ERKO5819551: Erkoflex, 4.00 mm, Ø 125 mm, gold. Thermoforming sheet material for the fabrication of orthodon
• ERKO5819531: Erkoflex, 4.00 mm, Ø 125 mm, pure white. Thermoforming sheet material for the fabrication of or
• ERKO5819481: Erkoflex, 4.00 mm, Ø 125 mm, light blue. Thermoforming sheet material for the fabrication of or
• ERKO5819471: Erkoflex, 4.00 mm, Ø 125 mm, night blue. Thermoforming sheet material for the fabrication of or
• ERKO5819461: Erkoflex, 4.00 mm, Ø 125 mm, deep red. Thermoforming sheet material for the fabrication of orth
• ERKO5819401: Erkoflex, 4.00 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication of o
• ERKO5819361: Erkoflex, 2.00 mm, Ø 125 mm, silver. Thermoforming sheet material for the fabrication of orthod
• ERKO5819351: Erkoflex, 2.00 mm, Ø 125 mm, gold. Thermoforming sheet material for the fabrication of orthodon
• ERKO5819281: Erkoflex, 2.00 mm, Ø 125 mm, light blue. Thermoforming sheet material for the fabrication of or
• ERKO5819251: Erkoflex, 2.00 mm, Ø 125 mm, bright pink. Thermoforming sheet material for the fabrication of o
• ERKO5819201: Erkoflex, 2.00 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication of o
• ERKO5812581: Erkoflex, 4.00 mm, Ø 120 mm, yolk yellow. Thermoforming sheet material for the fabrication of o
• ERKO5812571: Erkoflex, 4.00 mm, Ø 120 mm, orange. Thermoforming sheet material for the fabrication of orthod
• ERKO5812561: Erkoflex, 4.00 mm, Ø 120 mm, silver. Thermoforming sheet material for the fabrication of orthod