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, Tooth Shade, Resin (EBF) (6) Additively Manufactured, Preformed, Resin Denture Tooth (PZY) (4)

Premarket Exempt

No Yes

Clear

3Delta Crown - EDEL16112200 Catalog Number : 1611220

Device Description : 3Delta Crown A2 1000g

Device Class : 2

Duns Number: 344805101

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

3Delta Crown - EDEL16112300 Catalog Number : 1611230

Device Description : 3Delta Crown A3 1000g

Device Class : 2

Duns Number: 344805101

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

3Delta Crown - EDEL16112350 Catalog Number : 1611235

Device Description : 3Delta Crown A3.5 1000g

Device Class : 2

Duns Number: 344805101

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

3Delta Crown - EDEL16112500 Catalog Number : 1611250

Device Description : 3Delta Crown Bleach 1000g

Device Class : 2

Duns Number: 344805101

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

3Delta Crown - EDEL16112550 Catalog Number : 1611255

Device Description : 3Delta Crown B1 1000g

Device Class : 2

Duns Number: 344805101

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

3Delta Crown - EDEL16112600 Catalog Number : 1611260

Device Description : 3Delta Crown C1 1000g

Device Class : 2

Duns Number: 344805101

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

3Delta Denture Teeth - EDEL16120100 Catalog Number : 1612010

Device Description : 3Delta Denture Teeth A1 1000g

Device Class : 2

Duns Number: 344805101

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

3Delta Denture Teeth - EDEL16120200 Catalog Number : 1612020

Device Description : 3Delta Denture Teeth A2 1000g

Device Class : 2

Duns Number: 344805101

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

3Delta Denture Teeth - EDEL16120300 Catalog Number : 1612030

Device Description : 3Delta Denture Teeth A3 1000g

Device Class : 2

Duns Number: 344805101

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

3Delta Denture Teeth - EDEL16120350 Catalog Number : 1612035

Device Description : 3Delta Denture Teeth A3,5 1000g

Device Class : 2

Duns Number: 344805101

Premarket Exempt : Yes

Product Code : PZY

Prescription Use : Yes

Device Count : 1

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