Ext. Open-Tray Transfer XTOT-ER

GUDID 00810157312365

Ext. O-Tray Eng. Trans, 4.8mmD-4.8mmP

Paragon Implant Mfg., LLC

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810157312365
• NIH Device Record Key: b59dba61-cc28-4319-a1bd-58b858ec817f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ext. Open-Tray Transfer
• Version Model Number: XTOT-ER
• Catalog Number: XTOT-ER
• 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
• Phone: 1-855-649-4365
• Email: info@paragon-implant.com

Device Dimensions

• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter
• Outer Diameter: 4.8 Millimeter
• Length: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810157312365 [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

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

[00810157312365]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-14
• Device Publish Date: 2026-01-06

Devices Manufactured by Paragon Implant Mfg., LLC

• 00810157311566 - NizPlant Transfer: 2026-02-09 NizPlant NE Transfer, 4.3mmD-3.2mmP
• 00810157313706 - NizPlant Imp. Center Screw: 2026-02-09 NizPlant Imp. Center Screw (2 pcs)
• 00810157313751 - NizPlant Fixation Screw: 2026-02-09 NizPlant Fix. Screw, Ex. Short (2 pcs)
• 00810157314130 - Ext. NizLoc Abutment Screw: 2026-02-09 Ext. NizLoc Abut Screw, 0.25mmL-4.8mmP
• 00810157314147 - Ext. NizLoc Abutment Screw: 2026-02-09 Ext. NizLoc Abut Screw, 1.25mmL-4.8mmP
• 00810157314154 - Ext. NizLoc Abutment Screw: 2026-02-09 Ext. NizLoc Abut Screw, 2.25mmL-4.8mmP
• 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