Ext. Universal Fixation Screw XTFSL

GUDID 00810157312198

Ext. Univ. Fix. Screw, Long

Paragon Implant Mfg., LLC

Dental prosthesis/implant abutment screw

• Primary Device ID: 00810157312198
• NIH Device Record Key: 4e1ce662-e1e6-4e8f-922c-fbad6593d868
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ext. Universal Fixation Screw
• Version Model Number: XTFSL
• Catalog Number: XTFSL
• 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

Customer Support Contacts

• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com

Device Dimensions

• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810157312198 [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

[00810157312198]

Moist Heat or Steam Sterilization

[00810157312198]

Moist Heat or Steam Sterilization

[00810157312198]

Moist Heat or Steam Sterilization

[00810157312198]

Moist Heat or Steam Sterilization

[00810157312198]

Moist Heat or Steam Sterilization

[00810157312198]

Moist Heat or Steam Sterilization

[00810157312198]

Moist Heat or Steam Sterilization

[00810157312198]

Moist Heat or Steam Sterilization

[00810157312198]

Moist Heat or Steam Sterilization

[00810157312198]

Moist Heat or Steam Sterilization

[00810157312198]

Moist Heat or Steam Sterilization

[00810157312198]

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

Devices Manufactured by Paragon Implant Mfg., LLC

• 00810157313133 - NizLoc Abutment: 2026-02-06 NizLoc Abut, 1-Piece, 1.0mmL-3.5mmP
• 00810157313140 - NizLoc Abutment: 2026-02-06 NizLoc Abut, 1-Piece, 2.0mmL-3.5mmP
• 00810157313157 - NizLoc Abutment: 2026-02-06 NizLoc Abut, 1-Piece, 3.0mmL-3.5mmP
• 00810157313164 - NizLoc Abutment: 2026-02-06 NizLoc Abut, 1-Piece, 4.0mmL-3.5mmP
• 00810157313171 - NizLoc Abutment: 2026-02-06 NizLoc Abut, 1-Piece, 5.0mmL-3.5mmP
• 00810157313188 - NizLoc Abutment: 2026-02-06 NizLoc Abut, 1-Piece, 1.0mmL-4.5mmP
• 00810157313195 - NizLoc Abutment: 2026-02-06 NizLoc Abut, 1-Piece, 2.0mmL-4.5mmP
• 00810157313201 - NizLoc Abutment: 2026-02-06 NizLoc Abut, 1-Piece, 3.0mmL-4.5mmP