Proximerge 2

GUDID D985KTF1050

Tissue Forming Kit 10.5

Quadric Biomed, LLC

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: D985KTF1050
• NIH Device Record Key: df6ba4e5-17b3-4f84-ba68-c29a0db2df40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proximerge 2
• Version Model Number: KTF10.5
• Company DUNS: 080816716
• Company Name: Quadric Biomed, LLC
• 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: 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	D985KTF1050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211409

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

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: 2023-07-26
• Device Publish Date: 2023-07-18

On-Brand Devices [Proximerge 2]

• D985KSG1050: KSG10.5
• D985KSG910: KSG9.1
• D985KTF910: Tissue Forming Kit 9.1
• D985KTF1050: Tissue Forming Kit 10.5
• D985KRS910: Restorative Kit 9.1
• D985KRS1050: Restorative Kit 10.5