Nexplant M-AB354570

GUDID 08800024917375

Duplex Abutment Φ3.5/GH4.5/PH7.0 Hex

Achimhai Medical Corporation

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08800024917375
• NIH Device Record Key: 74ed2c2b-e30d-4fc2-938a-dc8e93a323a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexplant
• Version Model Number: M-AB354570
• Catalog Number: M-AB354570
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800024917375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170394

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08800024917375]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-07-29

On-Brand Devices [Nexplant]

• 08800024935324: Abutment Screw M1.4
• 08800024935119: Duplex Abutment Φ3.5/GH4.0/ANGLE25 Hex
• 08800024935102: Duplex Abutment Φ3.5/GH3.0/ANGLE25 Hex
• 08800024935096: Duplex Abutment Φ3.5/GH2.0/ANGLE25 Hex
• 08800024935089: Duplex Abutment Φ3.5/GH4.0/ANGLE15 Hex
• 08800024935072: Duplex Abutment Φ3.5/GH3.0/ANGLE15 Hex
• 08800024935065: Duplex Abutment Φ3.5/GH2.0/ANGLE15 Hex
• 08800024918808: Hex 1.2 / Short
• 08800024917771: Ø4.5 / Non-Hex
• 08800024917764: Ø4.5 / Hex
• 08800024917757: Ø4.0 / Non-Hex
• 08800024917740: Ø4.0 / Hex
• 08800024917467: Ø5.5 / H=7.0mm
• 08800024917450: Ø5.5 / H=5.0mm
• 08800024917443: Ø5.5 / H=3.5mm
• 08800024917436: Ø4.5 / H=7.0mm
• 08800024917429: Ø4.5 / H=5.0mm
• 08800024917412: Ø4.5 / H=3.5mm
• 08800024917405: Ø4.0 / H=7.0mm
• 08800024917399: Ø4.0 / H=5.0mm
• 08800024917382: Ø4.0 / H=3.5mm
• 08800024917375: Duplex Abutment Φ3.5/GH4.5/PH7.0 Hex
• 08800024917368: Duplex Abutment Φ3.5/GH3.5/PH7.0 Hex
• 08800024917351: Duplex Abutment Φ3.5/GH2.5/PH7.0 Hex
• 08800024917344: Duplex Abutment Φ3.5/GH1.5/PH7.0 Hex
• 08800024917337: Duplex Abutment Φ3.5/GH1.0/PH7.0 Hex
• 08800024917320: Duplex Abutment Φ3.5/GH4.5/PH5.5 Hex
• 08800024917313: Duplex Abutment Φ3.5/GH3.5/PH5.5 Hex
• 08800024917306: Duplex Abutment Φ3.5/GH2.5/PH5.5 Hex
• 08800024917290: Duplex Abutment Φ3.5/GH1.5/PH5.5 Hex
• 08800024917283: Duplex Abutment Φ3.5/GH1.0/PH5.5 Hex
• 08800024918839: Hex 3.5mm
• 08800024918822: Hex 1.25 / Short
• 08800024918815: Hex 1.25 / Long
• 08800024918792: Hex 1.2 / Long
• 08800024918785: Drill extension
• 08800024918228: Ø5.5 / Non-Hex / Long
• 08800024918211: Ø4.5 / Non-Hex / Long
• 08800024918204: Ø4.0 / Non-Hex / Long
• 08800024918198: Ø5.5 / Non-Hex / Short
• 08800024918181: Ø4.5 / Non-Hex / Short
• 08800024918174: Ø4.0 / Non-Hex / Short
• 08800024918082: Ø5.5 / Hex / Long
• 08800024918075: Ø4.5 / Hex / Long
• 08800024918068: Ø4.0 / Hex / Long
• 08800024918051: Ø5.5 / Hex / Short
• 08800024918044: Ø4.5 / Hex / Short
• 08800024918037: Ø4.0 / Hex / Short
• 08800024954615: Ø2.0 / Ø2.7
• 08800024954608: Ø5.0 / L=11.0mm