Extender Cover Screw XTCS2

GUDID 00810157312150

Ext. Cover Screw, 2.0mmL-4.8mmP

Paragon Implant Mfg., LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00810157312150
• NIH Device Record Key: 25719b0e-75e0-40a1-adbd-1fd8cab53e69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extender Cover Screw
• Version Model Number: XTCS2
• Catalog Number: XTCS2
• 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: 4.8 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810157312150 [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

[00810157312150]

Moist Heat or Steam Sterilization

[00810157312150]

Moist Heat or Steam Sterilization

[00810157312150]

Moist Heat or Steam Sterilization

[00810157312150]

Moist Heat or Steam Sterilization

[00810157312150]

Moist Heat or Steam Sterilization

[00810157312150]

Moist Heat or Steam Sterilization

[00810157312150]

Moist Heat or Steam Sterilization

[00810157312150]

Moist Heat or Steam Sterilization

[00810157312150]

Moist Heat or Steam Sterilization

[00810157312150]

Moist Heat or Steam Sterilization

[00810157312150]

Moist Heat or Steam Sterilization

[00810157312150]

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 [Extender Cover Screw]

• 00810157312167: Ext. Cover Screw, 3.0mmL-4.8mmP
• 00810157312150: Ext. Cover Screw, 2.0mmL-4.8mmP
• 00810157312143: Ext. Cover Screw, 1.0mmL-4.8mmP