Inosys

GUDID D124PMRBL0

Primus Blank 10mm Regular

Creo Dent Hudson Valley, Inc.

Dental implant suprastructure, permanent, custom-made

• Primary Device ID: D124PMRBL0
• NIH Device Record Key: 503bb0db-c9f9-423d-a7de-a597e153554f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inosys
• Version Model Number: PMRBL
• Company DUNS: 071221112
• Company Name: Creo Dent Hudson Valley, Inc.
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D124PMRBL0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160436

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

[D124PMRBL0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-26
• Device Publish Date: 2024-02-16

Devices Manufactured by Creo Dent Hudson Valley, Inc.

• D124CREOKORREKT0 - Creodent: 2024-08-28 Clear Aligner
• D124PMRBL0 - Inosys: 2024-02-26Primus Blank 10mm Regular
• D124PMRBL0 - Inosys: 2024-02-26 Primus Blank 10mm Regular
• D124NEOSS0 - SOLIDEX: 2023-09-22 TI LINK
• D124CL500 - Solidex: 2023-07-27 4.5mm Ti-Link Compatible with Camlog 5.0mm Implant Platform
• D124NB350 - Solidex: 2023-07-27 4.5mm Ti-Link Compatible with Nobel Biocare Replace NP Implant Platform
• D124NB3560 - Solidex: 2023-07-27 6mm Ti-Link Compatible with Nobel Biocare Replace NP Implant Platform
• D124NB35AS0 - Solidex: 2023-07-27 Angled Screw Compatible with Nobel Biocare Replace NP Implant Platform
• D124NB35B140 - Solidex: 2023-07-27 14mm Blank Compatible with Nobel Biocare Replace NP Implant Platform