sewon medix Inc.

Address:#29, Sasang-ro, 375 beon-gil, Sasang-gu,Busan,KR

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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) (10)

Premarket Exempt

Clear

XP-I SLA Fixture - 08800041365524 Catalog Number : BIH2FR3513S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x13.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

XP-I SLA Fixture - 08800041365531 Catalog Number : BIH2FR3515S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x15.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

XP-I SLA Fixture - 08800041365548 Catalog Number : BIH2FR4007S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x7.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

XP-I SLA Fixture - 08800041365555 Catalog Number : BIH2FR4008S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x8.5mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

XP-I SLA Fixture - 08800041365562 Catalog Number : BIH2FR4010S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x10.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

XP-I SLA Fixture - 08800041365579 Catalog Number : BIH2FR4011S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x11.5mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

XP-I SLA Fixture - 08800041365586 Catalog Number : BIH2FR4013S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x13.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

XP-I SLA Fixture - 08800041365593 Catalog Number : BIH2FR4015S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x15.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

XP-I SLA Fixture - 08800041365609 Catalog Number : BIH2FR4507S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x7.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

XP-I SLA Fixture - 08800041365616 Catalog Number : BIH2FR4508S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x8.5mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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