pro3dure medical GmbH

Address:Am Burgberg 13,Iserlohn North Rhine-Westphalia,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

Hearing Aid, Air Conduction (ESD) (7) Mouthguard, Prescription (MQC) (3) Positioner, Tooth, Preformed (KMY) (1) Resin, Denture, Relining, Repairing, Rebasing (EBI) (1)

Premarket Exempt

No Yes

Clear

CORiTEC Splint Comfort - 01111111111116 Catalog Number : PEMCR00016

Device Description : CORiTEC disc, diameter 98.5 mm, height 16 mm

Device Class : U

Duns Number: 312947842

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

CORiTEC Splint Comfort - 01111111111123 Catalog Number : PEMCR00020

Device Description : CORiTEC disc, diameter 98.5 mm, height 20 mm

Device Class : U

Duns Number: 312947842

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

dima Print Splint clear - EPRC66077916 Catalog Number :

Device Description : Light curing liquid for 3D-printing

Device Class : 1

Duns Number: 312947842

Premarket Exempt : No

Product Code : MQC, EBI, KMY

Prescription Use : Yes

Device Count : 1

PRO3DURE IS-1.1 - EPRCA0010100 Catalog Number :

Device Description : IS-1.1 - 8 double cartridges of 2 x 25 ml

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

otosil ES-1.1 - EPRCA0030100 Catalog Number : A0030100

Device Description : ES-1.1 / 25 Shore white-opaque 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0030203 Catalog Number : A0030203

Device Description : ES-1.1 / 25 Shore reddish-transparent 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0030376 Catalog Number : A0030376

Device Description : ES-1.1 / 25 Shore black-opaque 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0030428 Catalog Number : A0030428

Device Description : ES-1.1 / 25 Shore dark-blue opaque 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0030530 Catalog Number : A0030530

Device Description : ES-1.1 / 25 Shore neon-green opaque 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

otosil ES-1.1 - EPRCA0030627 Catalog Number : A0030627

Device Description : ES-1.1 / 25 Shore red opaque 8 double cartridges with 48 ml each

Device Class : 1

Duns Number: 312947842

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : Yes

Device Count : 1

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