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 IDERKO5842512
NIH Device Record Keyd43134a0-c397-48da-8cba-1cbac903acf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameErkoflex
Version Model Number584251
Company DUNS317654200
Company NameErkodent Erich Kopp GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCERKO5842512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQCMouthguard, Prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-03
Device Publish Date2021-08-26

On-Brand Devices [Erkoflex]

ERKO5842582Erkoflex, 4.00 mm, Ø 120 mm, yolk yellow. Thermoforming sheet material for the fabrication of o
ERKO5842572Erkoflex, 4.00 mm, Ø 120 mm, orange. Thermoforming sheet material for the fabrication of orthod
ERKO5842562Erkoflex, 4.00 mm, Ø 120 mm, silver. Thermoforming sheet material for the fabrication of orthod
ERKO5842552Erkoflex, 4.00 mm, Ø 120 mm, gold. Thermoforming sheet material for the fabrication of orthodon
ERKO5842542Erkoflex, 4.00 mm, Ø 120 mm, deep black. Thermoforming sheet material for the fabrication of or
ERKO5842532Erkoflex, 4.00 mm, Ø 120 mm, pure white. Thermoforming sheet material for the fabrication of or
ERKO5842522Erkoflex, 4.00 mm, Ø 120 mm, deep green. Thermoforming sheet material for the fabrication of or
ERKO5842512Erkoflex, 4.00 mm, Ø 120 mm, maroon. Thermoforming sheet material for the fabrication of orthod
ERKO5842482Erkoflex, 4.00 mm, Ø 120 mm, light blue. Thermoforming sheet material for the fabrication of or
ERKO5842472Erkoflex, 4.0 mm, Ø 120 mm, night blue. Thermoforming sheet material for the fabrication of ort
ERKO5842462Erkoflex, 4.00 mm, Ø 120 mm, deep red. Thermoforming sheet material for the fabrication of orth
ERKO5842452Erkoflex, 4.00 mm, Ø 120 mm, bright pink. Thermoforming sheet material for the fabrication of o
ERKO5842442Erkoflex, 4.00 mm, Ø 120 mm, bright green. Thermoforming sheet material for the fabrication of
ERKO5842432Erkoflex, 4.00 mm, Ø 120 mm, bright blue. Thermoforming sheet material for the fabrication of o
ERKO5842422Erkoflex, 4.00 mm, Ø 120 mm, bright yellow. Thermoforming sheet material for the fabrication of
ERKO5842412Erkoflex, 4.00 mm, Ø 120 mm, bright red. Thermoforming sheet material for the fabrication of or
ERKO5842372Erkoflex, 2.00 mm, Ø 120 mm, orange. Thermoforming sheet material for the fabrication of orthod
ERKO5842362Erkoflex, 2.00 mm, Ø 120 mm, silver. Thermoforming sheet material for the fabrication of orthod
ERKO5842352Erkoflex, 2.00 mm, Ø 120 mm, gold. Thermoforming sheet material for the fabrication of orthodon
ERKO5842342Erkoflex, 2.00 mm, Ø 120 mm, deep black. Thermoforming sheet material for the fabrication of or
ERKO5842332Erkoflex, 2.00 mm, Ø 120 mm, pure white. Thermoforming sheet material for the fabrication of or
ERKO5842322Erkoflex, 2.00 mm, Ø 120 mm, deep green. Thermoforming sheet material for the fabrication of or
ERKO5842312Erkoflex, 2.00 mm, Ø 120 mm, maroon. Thermoforming sheet material for the fabrication of orthod
ERKO5842282Erkoflex, 2.00 mm, Ø 120 mm, light blue. Thermoforming sheet material for the fabrication of or
ERKO5842272Erkoflex, 2.00 mm, Ø 120 mm, night blue. Thermoforming sheet material for the fabrication of or
ERKO5842262Erkoflex, 2.00 mm, Ø 120 mm, deep red. Thermoforming sheet material for the fabrication of orth
ERKO5842252Erkoflex, 2.00 mm, Ø 120 mm, bright pink. Thermoforming sheet material for the fabrication of o
ERKO5842242Erkoflex, 2.00 mm, Ø 120 mm, bright green. Thermoforming sheet material for the fabrication of
ERKO5842232Erkoflex, 2.00 mm, Ø 120 mm, bright blue. Thermoforming sheet material for the fabrication of o
ERKO5842222Erkoflex, 2.00 mm, Ø 120 mm, bright yellow. Thermoforming sheet material for the fabrication of
ERKO5842212Erkoflex, 2.00 mm, Ø 120 mm, bright red. Thermoforming sheet material for the fabrication of or
ERKO5832403Erkoflex, 4.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of o
ERKO5832303Erkoflex, 3.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of o
ERKO5832203Erkoflex, 2.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of o
ERKO5832153Erkoflex, 1.50 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of o
ERKO5832103Erkoflex, 1.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the fabrication of o
ERKO5819551Erkoflex, 4.00 mm, Ø 125 mm, gold. Thermoforming sheet material for the fabrication of orthodon
ERKO5819531Erkoflex, 4.00 mm, Ø 125 mm, pure white. Thermoforming sheet material for the fabrication of or
ERKO5819481Erkoflex, 4.00 mm, Ø 125 mm, light blue. Thermoforming sheet material for the fabrication of or
ERKO5819471Erkoflex, 4.00 mm, Ø 125 mm, night blue. Thermoforming sheet material for the fabrication of or
ERKO5819461Erkoflex, 4.00 mm, Ø 125 mm, deep red. Thermoforming sheet material for the fabrication of orth
ERKO5819401Erkoflex, 4.00 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication of o
ERKO5819361Erkoflex, 2.00 mm, Ø 125 mm, silver. Thermoforming sheet material for the fabrication of orthod
ERKO5819351Erkoflex, 2.00 mm, Ø 125 mm, gold. Thermoforming sheet material for the fabrication of orthodon
ERKO5819281Erkoflex, 2.00 mm, Ø 125 mm, light blue. Thermoforming sheet material for the fabrication of or
ERKO5819251Erkoflex, 2.00 mm, Ø 125 mm, bright pink. Thermoforming sheet material for the fabrication of o
ERKO5819201Erkoflex, 2.00 mm, Ø 125 mm, transparent. Thermoforming sheet material for the fabrication of o
ERKO5812581Erkoflex, 4.00 mm, Ø 120 mm, yolk yellow. Thermoforming sheet material for the fabrication of o
ERKO5812571Erkoflex, 4.00 mm, Ø 120 mm, orange. Thermoforming sheet material for the fabrication of orthod
ERKO5812561Erkoflex, 4.00 mm, Ø 120 mm, silver. Thermoforming sheet material for the fabrication of orthod

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