Actifix CC Conical Narrow Platform BIOS3510CC

GUDID D169BSCC3510

QUICKDENT DEVICES PRIVATE LIMITED

Dental implant system

• Primary Device ID: D169BSCC3510
• NIH Device Record Key: c52a59f9-9077-4c33-a075-48292f8a7cfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actifix CC Conical Narrow Platform
• Version Model Number: 3.5 x 10mm
• Catalog Number: BIOS3510CC
• Company DUNS: 860405444
• Company Name: QUICKDENT DEVICES PRIVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D169BSCC3510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243094

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: 2025-08-04
• Device Publish Date: 2025-07-25

On-Brand Devices [Actifix CC Conical Narrow Platform]

• D169BSCC3516: 3.5 x 16mm
• D169BSCC3513: 3.5 x 13mm
• D169BSCC3511: 3.5 x 11.5mm
• D169BSCC3510: 3.5 x 10mm
• D169BSCC3508: 3.5 x 8mm
• D169BSCC4216: 4.2 x 13mm
• D169BSCC4213: 4.2 x 13mm
• D169BSCC4211: 4.2 x 11mm
• D169BSCC4210: 4.2 x 10mm
• D169BSCC4208: 4.2 x 8mm
• D169BSCC0516: 5.0 x 16mm
• D169BSCC0513: 5.0 x 13mm
• D169BSCC0511: 5.0 x 11.5mm
• D169BSCC0510: 5.0 x 10mm
• D169BSCC0508: 5.0 x 8mm