Universal Fixation Screw UFSXL

GUDID 00810157312099

Univ. Fix. Screw, X-Long Screw

Paragon Implant Mfg., LLC

Dental prosthesis/implant abutment screw

• Primary Device ID: 00810157312099
• NIH Device Record Key: 7edfd8a4-6e6a-4256-bf25-9a318d8d3ae3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Fixation Screw
• Version Model Number: UFSXL
• Catalog Number: UFSXL
• Company DUNS: 118698566
• Company Name: Paragon Implant Mfg., LLC
• 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 Dimensions

• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter
• Outer Diameter: 2.2 Millimeter
• Length: 24.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810157312099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251938

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00810157312099]

Moist Heat or Steam Sterilization

[00810157312099]

Moist Heat or Steam Sterilization

[00810157312099]

Moist Heat or Steam Sterilization

[00810157312099]

Moist Heat or Steam Sterilization

[00810157312099]

Moist Heat or Steam Sterilization

[00810157312099]

Moist Heat or Steam Sterilization

[00810157312099]

Moist Heat or Steam Sterilization

[00810157312099]

Moist Heat or Steam Sterilization

[00810157312099]

Moist Heat or Steam Sterilization

[00810157312099]

Moist Heat or Steam Sterilization

[00810157312099]

Moist Heat or Steam Sterilization

[00810157312099]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-15
• Device Publish Date: 2026-01-07

On-Brand Devices [Universal Fixation Screw]

• 00810157312099: Univ. Fix. Screw, X-Long Screw
• 00810157312075: Univ. Fix. Screw, Long