Erkodent Erich Kopp GmbH

Address:SIEMENSSTR. 3,PFALZGRAFENWEILER Baden-Wurttemberg,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Mouthguard, Prescription (MQC) (10) Positioner, Tooth, Preformed (KMY) (10)

Premarket Exempt

Clear

Erkodur - ERKO5232203 Catalog Number :

Device Description : Erkodur, 2.00 mm, Ø 120 mm, clear. Thermoforming sheet material for the fabricat Erkodur, 2.00 mm, Ø 120 mm, clear. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Device Class : 1

Duns Number: 317654200

Premarket Exempt : No

Product Code : MQC, KMY

Prescription Use : Yes

Device Count : 1

Erkodur - ERKO5232303 Catalog Number :

Device Description : Erkodur, 3.00 mm, Ø 120 mm, clear. Thermoforming sheet material for the fabricat Erkodur, 3.00 mm, Ø 120 mm, clear. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Device Class : 1

Duns Number: 317654200

Premarket Exempt : No

Product Code : MQC, KMY

Prescription Use : Yes

Device Count : 1

Erkodur - ERKO5232403 Catalog Number :

Device Description : Erkodur, 4.00 mm, Ø 120 mm, clear. Thermforming sheet material for the fabricati Erkodur, 4.00 mm, Ø 120 mm, clear. Thermforming sheet material for the fabrication of orthodontic and dental appliances.

Device Class : 1

Duns Number: 317654200

Premarket Exempt : No

Product Code : MQC, KMY

Prescription Use : Yes

Device Count : 1

Erkodur - ERKO5232503 Catalog Number :

Device Description : Erkodur, 5.00 mm, Ø 120 mm, clear. Thermoforming sheet material for the fabricat Erkodur, 5.00 mm, Ø 120 mm, clear. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Device Class : 1

Duns Number: 317654200

Premarket Exempt : No

Product Code : MQC, KMY

Prescription Use : Yes

Device Count : 1

Erkodur - ERKO5242052 Catalog Number :

Device Description : Erkodur, 0.50 mm, Ø 120 mm, clear. Thermoforming sheet material for the fabricat Erkodur, 0.50 mm, Ø 120 mm, clear. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Device Class : 1

Duns Number: 317654200

Premarket Exempt : No

Product Code : MQC, KMY

Prescription Use : Yes

Device Count : 1

Erkodur - ERKO5242202 Catalog Number :

Device Class : 1

Duns Number: 317654200

Premarket Exempt : No

Product Code : MQC, KMY

Prescription Use : Yes

Device Count : 1

Erkodur-0M1 - ERKO5261061 Catalog Number :

Device Description : Erkodur-0M1, 0.60 mm, Ø 120 mm, tooth colour. Thermoforming sheet material for t Erkodur-0M1, 0.60 mm, Ø 120 mm, tooth colour. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Device Class : 1

Duns Number: 317654200

Premarket Exempt : No

Product Code : MQC, KMY

Prescription Use : Yes

Device Count : 1

Erkodur-0M1 - ERKO5261101 Catalog Number :

Device Description : Erkodur-0M1, 1.00 mm, Ø 120 mm, tooth colour. Thermoforming sheet material for t Erkodur-0M1, 1.00 mm, Ø 120 mm, tooth colour. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Device Class : 1

Duns Number: 317654200

Premarket Exempt : No

Product Code : MQC, KMY

Prescription Use : Yes

Device Count : 1

Erkodur-A3 - ERKO5262101 Catalog Number :

Device Description : Erkodur-A3, 1.00 mm, Ø 120 mm, tooth colour. Thermoforming sheet material for th Erkodur-A3, 1.00 mm, Ø 120 mm, tooth colour. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Device Class : 1

Duns Number: 317654200

Premarket Exempt : No

Product Code : MQC, KMY

Prescription Use : Yes

Device Count : 1

Erkodur-A3 - ERKO5262201 Catalog Number :

Device Description : Erkodur-A3, 2.00 mm, Ø 120 mm, tooth colour. Thermoforming sheet material for th Erkodur-A3, 2.00 mm, Ø 120 mm, tooth colour. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.

Device Class : 1

Duns Number: 317654200

Premarket Exempt : No

Product Code : MQC, KMY

Prescription Use : Yes

Device Count : 1

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