IH2 Fixture SLA AIH2FR4508S

GUDID 08800041300921

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

sewon medix Inc.

Fixture/appliance dental drill bit, single-use

• Primary Device ID: 08800041300921
• NIH Device Record Key: 6eb89071-61ea-4760-acfe-a0081e0dc481
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IH2 Fixture SLA
• Version Model Number: AIH2FR4508S
• Catalog Number: AIH2FR4508S
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800041300921 [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: 2019-07-10
• Device Publish Date: 2019-07-02

On-Brand Devices [IH2 Fixture SLA]

• 08800041300983: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø5.0x8.5mm
• 08800041300921: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.5x8.5mm
• 08800041300860: SEWON MEDIX IH2 SLA Fixture Regular Set Product, Ø4.0x8.5mm
• 08800041300761: SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x11.5mm
• 08800041300754: SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x10.0mm
• 08800041300778: SEWON MEDIX IH2 SLA Fixture Mini Set Product, Ø3.5x13.0mm