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

Erkoflex - ERKO5812301 Catalog Number :

Device Description : Erkoflex, 3.00 mm, Ø 120 mm, transparent. Thermoforming sheet material for the f Erkoflex, 3.00 mm, Ø 120 mm, transparent. 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

Erkoflex - ERKO5812311 Catalog Number :

Device Description : Erkoflex, 2.00 mm, Ø 120 mm, maroon. Thermoforming sheet material for the fabric Erkoflex, 2.00 mm, Ø 120 mm, maroon. 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

Erkoflex - ERKO5812321 Catalog Number :

Device Description : Erkoflex, 2.00 mm, Ø 120 mm, deep green. Thermoforming sheet material for the fa Erkoflex, 2.00 mm, Ø 120 mm, deep green. 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

Erkoflex - ERKO5812331 Catalog Number :

Device Description : Erkoflex, 2.00 mm, Ø 120 mm, pure white. Thermoforming sheet material for the fa Erkoflex, 2.00 mm, Ø 120 mm, pure white. 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

Erkoflex - ERKO5812341 Catalog Number :

Device Description : Erkoflex, 2.00 mm, Ø 120 mm, deep black. Thermoforming sheet material for the fa Erkoflex, 2.00 mm, Ø 120 mm, deep black. 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

Erkoflex - ERKO5812351 Catalog Number :

Device Description : Erkoflex, 2.00 mm, Ø 120 mm, gold. Thermoforming sheet material for the fabricat Erkoflex, 2.00 mm, Ø 120 mm, gold. 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

Erkoflex - ERKO5812361 Catalog Number :

Device Description : Erkoflex, 2.00 mm, Ø 120 mm, silver. Thermoforming sheet material for the fabric Erkoflex, 2.00 mm, Ø 120 mm, silver. 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

Erkoflex - ERKO5812411 Catalog Number :

Device Description : Erkoflex, 4.00 mm, Ø 120 mm, bright red . Thermoforming sheet material for the f Erkoflex, 4.00 mm, Ø 120 mm, bright red . 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

Erkoflex - ERKO5812421 Catalog Number :

Device Description : Erkoflex, 4.00 mm, Ø 120 mm, bright yellow. Thermoforming sheet material for the Erkoflex, 4.00 mm, Ø 120 mm, bright yellow. 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

Erkoflex - ERKO5812431 Catalog Number :

Device Description : Erkoflex, 4.00 mm, Ø 120 mm, bright blue. Thermoforming sheet material for the f Erkoflex, 4.00 mm, Ø 120 mm, bright blue. 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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