XP-I SLA Fixture BIH2FR3510S

GUDID 08800041365500

SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x10.0mm

sewon medix Inc.

Fixture/appliance dental drill bit, single-use

• Primary Device ID: 08800041365500
• NIH Device Record Key: 7f9e30a3-46ed-453e-b7f4-75f8ae52a46e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XP-I SLA Fixture
• Version Model Number: BIH2FR3510S
• Catalog Number: BIH2FR3510S
• Company DUNS: 688731065
• Company Name: sewon medix Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800041365500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153521

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-24
• Device Publish Date: 2022-02-16

On-Brand Devices [XP-I SLA Fixture]

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• 08800041365708: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x13.0mm
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• 08800041365685: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x10.0mm
• 08800041365678: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x8.5mm
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• 08800041365654: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x15.0mm
• 08800041365647: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x13.0mm
• 08800041365630: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x11.5mm
• 08800041365623: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x10.0mm
• 08800041365616: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x8.5mm
• 08800041365609: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x7.0mm
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• 08800041365586: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x13.0mm
• 08800041365579: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x11.5mm
• 08800041365562: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x10.0mm
• 08800041365555: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x8.5mm
• 08800041365548: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x7.0mm
• 08800041365531: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x15.0mm
• 08800041365524: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x13.0mm
• 08800041365517: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x11.5mm
• 08800041365500: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x10.0mm
• 08800041365494: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x8.5mm
• 08800041365487: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x7.0mm
• 08800041365470: SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x15.0mm
• 08800041365463: SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x13.0mm
• 08800041365456: SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x11.5mm
• 08800041365449: SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x10.0mm
• 08800041365432: SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x8.5mm
• 08800041365371: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x15.0mm
• 08800041365364: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x13.0mm
• 08800041365357: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x11.5mm
• 08800041365340: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x10.0mm
• 08800041365333: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x8.5mm
• 08800041365326: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x7.0mm
• 08800041365319: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x15.0mm
• 08800041365302: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x13.0mm
• 08800041365296: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x11.5mm
• 08800041365289: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x10.0mm
• 08800041365272: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x8.5mm
• 08800041365265: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x7.0mm
• 08800041365258: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x15.0mm
• 08800041365241: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x13.0mm
• 08800041365234: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x11.5mm
• 08800041365227: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x10.0mm
• 08800041365210: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x8.5mm
• 08800041365203: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x7.0mm
• 08800041365197: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x15.0mm
• 08800041365180: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø3.5x13.0mm
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