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) (6) Abutment, Implant, Dental, Endosseous (NHA) (4)

Premarket Exempt

Clear

IH2 Fixture SLA - 08800041300945 Catalog Number : AIH2FR4511S

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

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

IH2 Fixture SLA - 08800041300969 Catalog Number : AIH2FR4515S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x15.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

IH2 Fixture SLA - 08800041300983 Catalog Number : AIH2FR5008S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x8.5mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

IH2 Fixture SLA - 08800041300990 Catalog Number : AIH2FR5010S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x10.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

IH2 Fixture SLA - 08800041301027 Catalog Number : AIH2FR5015S

Device Description : SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x15.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

IH2 Fixture SLA - 08800041301430 Catalog Number : AIH2FM3510SD

Device Description : SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x10.0mm, HEX 2.5mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

IH2 Healing Abutment - 08800041302215 Catalog Number : IHHAM403

Device Description : SEWON MEDIX IH Healing Abutment Mini, Ø4.0x3.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

IH2 Healing Abutment - 08800041302222 Catalog Number : IHHAM405

Device Description : SEWON MEDIX IH Healing Abutment Mini, Ø4.0x5.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

IH2 Healing Abutment - 08800041302239 Catalog Number : IHHAM407

Device Description : SEWON MEDIX IH Healing Abutment Mini, Ø4.0x7.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

IH2 Healing Abutment - 08800041302246 Catalog Number : IHHAM453

Device Description : SEWON MEDIX IH Healing Abutment Mini, Ø4.5x3.0mm

Device Class : 2

Duns Number: 688731065

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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