DeltaMed GmbH

Address:RAIFFEISENSTR. 8a,FRIEDBERG Hesse,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

Material, Impression Tray, Resin (EBH) (4) Plate, Base, Shellac (EEA) (2) Additively Manufactured, Preformed, Resin Denture Tooth (PZY) (1)

Premarket Exempt

Yes No

Clear

3Delta Denture Teeth - EDEL16122100 Catalog Number : 1612210

Device Description : 3Delta Denture Teeth C1 1000g

Device Class : 2

Duns Number: 344805101

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

3Delta Try-In - EDEL16211100 Catalog Number : 1621110

Device Description : 3Delta Try-In 500g

Device Class : 1

Duns Number: 344805101

Premarket Exempt : Yes

Product Code : EEA

Prescription Use : Yes

Device Count : 1

3Delta Try-In - EDEL16211200 Catalog Number : 1621120

Device Description : 3Delta Try-In 1000g

Device Class : 1

Duns Number: 344805101

Premarket Exempt : Yes

Product Code : EEA

Prescription Use : Yes

Device Count : 1

3Delta Tray - EDEL16212100 Catalog Number : 1621210

Device Description : 3Delta Tray (green) 500g

Device Class : 1

Duns Number: 344805101

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

3Delta Tray - EDEL16212200 Catalog Number : 1621220

Device Description : 3Delta Tray (green) 1000g

Device Class : 1

Duns Number: 344805101

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

3Delta Tray - EDEL16213100 Catalog Number : 1621310

Device Description : 3Delta Tray beige 500g

Device Class : 1

Duns Number: 344805101

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

3Delta Tray - EDEL16213200 Catalog Number : 1621320

Device Description : 3Delta Tray beige 1000g

Device Class : 1

Duns Number: 344805101

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : Yes

Device Count : 1

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