Ext. NizLoc Abutment Screw XTNL-1

GUDID 00810157314147

Ext. NizLoc Abut Screw, 1.25mmL-4.8mmP

Paragon Implant Mfg., LLC

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810157314147
• NIH Device Record Key: 4772ef65-217b-46b1-9028-599e395e630a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ext. NizLoc Abutment Screw
• Version Model Number: XTNL-1
• Catalog Number: XTNL-1
• 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

Device Dimensions

• Outer Diameter: 4.8 Millimeter
• Length: 1.25 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 1.25 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 1.25 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 1.25 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 1.25 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 1.25 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 1.25 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 1.25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810157314147 [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

[00810157314147]

Moist Heat or Steam Sterilization

[00810157314147]

Moist Heat or Steam Sterilization

[00810157314147]

Moist Heat or Steam Sterilization

[00810157314147]

Moist Heat or Steam Sterilization

[00810157314147]

Moist Heat or Steam Sterilization

[00810157314147]

Moist Heat or Steam Sterilization

[00810157314147]

Moist Heat or Steam Sterilization

[00810157314147]

Moist Heat or Steam Sterilization

[00810157314147]

Moist Heat or Steam Sterilization

[00810157314147]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-09
• Device Publish Date: 2026-01-30

On-Brand Devices [Ext. NizLoc Abutment Screw]

• 00810157314154: Ext. NizLoc Abut Screw, 2.25mmL-4.8mmP
• 00810157314147: Ext. NizLoc Abut Screw, 1.25mmL-4.8mmP
• 00810157314130: Ext. NizLoc Abut Screw, 0.25mmL-4.8mmP