ACTILINK™

GUDID 08800066500269

The ACTILINK reborn is a device intended for use in reducing carbon contamination level on dental implant surface by means of plasma enhanced vacuuming, in a chairside.

Plasmapp Co.,Ltd.

Plasma sterilizer

• Primary Device ID: 08800066500269
• NIH Device Record Key: af9b9dd2-800c-4385-b13e-4296a63ff110
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTILINK™
• Version Model Number: ACTILINK reborn
• Company DUNS: 695798956
• Company Name: Plasmapp Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800066500269 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-06
• Device Publish Date: 2023-02-24

On-Brand Devices [ACTILINK™]

• 08800066500245: The ACTILINK mini is indicated for removing the hydrocarbon impurities on the surface of the end
• 08800066500269: The ACTILINK reborn is a device intended for use in reducing carbon contamination level on denta