GDIFF IB-T PFX-3807SD-C

GUDID 08800024909769

GDIFF IB-T implant fixture Φ3.8/L7.0

Achimhai Medical Corporation

Screw endosteal dental implant, two-piece

• Primary Device ID: 08800024909769
• NIH Device Record Key: 9cdf3551-bd6b-4b54-9218-3bb1d998e37f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GDIFF IB-T
• Version Model Number: PFX-3807SD
• Catalog Number: PFX-3807SD-C
• Company DUNS: 694197900
• Company Name: Achimhai Medical Corporation
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800024909769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172630

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-12-30
• Device Publish Date: 2018-04-30

Devices Manufactured by Achimhai Medical Corporation

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• 08800024957593 - AIMGEN MAX: 2022-07-13 AIMGEN MAX Ball Abutment Ø3.5 / GH=3.0mm
• 08800024957609 - AIMGEN MAX: 2022-07-13 AIMGEN MAX Ball Driver Hex 2.4 / Short
• 08800024957616 - AIMGEN MAX: 2022-07-13 AIMGEN MAX Multi Driver Hex 2.0 / Short
• 08800024957623 - AIMGEN MAX: 2022-07-13 AIMGEN MAX Multi Driver Hex 2.0 / Long
• 08800024957630 - AIMGEN MAX: 2022-07-13 AIMGEN MAX Torque Wrench Connector Square 4.0mm
• 08800024957647 - AIMGEN MAX: 2022-07-13 AIMGEN MAX Multi Transfer Impression Coping Multi / Ø4.8