Korticale TPR IH BITP3510IH

GUDID D169BPIH3510

QUICKDENT DEVICES PRIVATE LIMITED

Dental implant system

• Primary Device ID: D169BPIH3510
• NIH Device Record Key: e15b94f8-2606-477a-9995-70971244e54c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Korticale TPR IH
• Version Model Number: 3.5 x 10mm
• Catalog Number: BITP3510IH
• 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	D169BPIH3510 [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: 2025-07-09
• Device Publish Date: 2025-07-01

On-Brand Devices [Korticale TPR IH]

• D169BPIH4216: 4.2 x 16mm
• D169BPIH4214: 4.2 x 14mm
• D169BPIH4212: 4.2 x 12mm
• D169BPIH4210: 4.2 x 10mm
• D169BPIH3516: 3.5 x 16mm
• D169BPIH3514: 3.5 x 14mm
• D169BPIH3512: 3.5 x 12mm
• D169BPIH3510: 3.5 x 10mm