3shape Trios A/S

Address:Holmens Kanal 7,copenhagen Hovedstaden,DK

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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

Accessories, Implant, Dental, Endosseous (NDP) (10)

Premarket Exempt

No Yes

Clear

3Shape Scan Bodies - 05902729751537 Catalog Number :

Device Description : ASTRA TECH - Screwdriver

Device Class : 1

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

3Shape Scan Bodies - 05902729751544 Catalog Number :

Device Description : ASTRA TECH - Narrow platform - Connection: X-Small (3,0)

Device Class : 1

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

3Shape Scan Bodies - 05902729751551 Catalog Number :

Device Description : ASTRA TECH - Regular platform - Connection: Small (3.5, 4.0)

Device Class : 1

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

3Shape Scan Bodies - 05902729751568 Catalog Number :

Device Description : ASTRA TECH - Regular platform - Connection: Large (4.5, 5.0)

Device Class : 1

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

3Shape Scan Bodies - 05902729751582 Catalog Number :

Device Description : System box only

Device Class : 1

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

3Shape Scan Bodies - 05902729751599 Catalog Number :

Device Description : XiVE - Screwdriver

Device Class : 1

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

3Shape Scan Bodies - 05902729751605 Catalog Number :

Device Description : XiVE - Narrow platform - Connection: 3,0

Device Class : 1

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

3Shape Scan Bodies - 05902729751612 Catalog Number :

Device Description : XiVE - Regular platform - Connection: 3,4

Device Class : 1

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

3Shape Scan Bodies - 05902729751629 Catalog Number :

Device Description : XiVE - Regular platform - Connection: 3,8

Device Class : 1

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

3Shape Scan Bodies - 05902729751636 Catalog Number :

Device Description : XiVE - Regular platform - Connection: 4,5

Device Class : 1

Duns Number: 305225025

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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