Trabecos IH Internal Hex BOLR3508IH

GUDID D169BRIH3508

QUICKDENT DEVICES PRIVATE LIMITED

Dental implant system

• Primary Device ID: D169BRIH3508
• NIH Device Record Key: 7dd575b0-01aa-4f3b-9001-47ba483972e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trabecos IH Internal Hex
• Version Model Number: 3.5 x 8mm
• Catalog Number: BOLR3508IH
• 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	D169BRIH3508 [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: 2025-08-20
• Device Publish Date: 2025-08-12

On-Brand Devices [Trabecos IH Internal Hex]

• D169BRIH4216: 4.2 x 16mm
• D169BRIH4213: 4.2 x 13mm
• D169BRIH4211: 4.2 x 11.5mm
• D169BRIH4210: 4.2 x 10mm
• D169BRIH4208: 4.2 x 8mm
• D169BRIH3516: 3.5 x 16mm
• D169BRIH3513: 3.5 x 13mm
• D169BRIH3511: 3.5 x 11.5mm
• D169BRIH3510: 3.5 x 10mm
• D169BRIH3508: 3.5 x 8mm
• D169BRIH0613: 6.0 x 13mm
• D169BRIH0611: 6.0 x 11.5mm
• D169BRIH0610: 6.0 x 10mm
• D169BRIH0608: 6.0 x 8mm
• D169BRIH0516: 5.0 x 16mm
• D169BRIH0513: 5.0 x 13mm
• D169BRIH0511: 5.0 x 11.5mm
• D169BRIH0510: 5.0 x 10mm
• D169BRIH0508: 5.0 x 8mm