ORTHOLUTION CO.,LTD.

ORTHOLUTION CO.,LTD.

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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

Implant, Endosseous, Root-Form (DZE) (3)

Premarket Exempt

No

Clear

ORLUS MINI SCREW - 08809283891808 Catalog Number : 1O18212

Device Class : 2

Duns Number: 689964302

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

ORLUS MINI SCREW - 08809283891822 Catalog Number : 1O18213

Device Class : 2

Duns Number: 689964302

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

ORLUS MINI SCREW - 08809283891846 Catalog Number : 1O18308

Device Class : 2

Duns Number: 689964302

Premarket Exempt : No

Product Code : DZE

Prescription Use : No

Device Count : 1

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