GEN5+™ Implant NWP5212

GUDID 00810157310538

GEN5+ Imp. 5.2mmD-12.5mmL-4.5mmP

Paragon Implant Mfg., LLC

Dental implant system

• Primary Device ID: 00810157310538
• NIH Device Record Key: 8ebcfc3f-936e-40ae-a6a5-b4c12c09360e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEN5+™ Implant
• Version Model Number: NWP5212
• Catalog Number: NWP5212
• 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

Device Dimensions

• Outer Diameter: 5.2 Millimeter
• Length: 12.5 Millimeter
• Outer Diameter: 5.2 Millimeter
• Length: 12.5 Millimeter
• Outer Diameter: 5.2 Millimeter
• Length: 12.5 Millimeter
• Outer Diameter: 5.2 Millimeter
• Length: 12.5 Millimeter
• Outer Diameter: 5.2 Millimeter
• Length: 12.5 Millimeter
• Outer Diameter: 5.2 Millimeter
• Length: 12.5 Millimeter
• Outer Diameter: 5.2 Millimeter
• Length: 12.5 Millimeter
• Outer Diameter: 5.2 Millimeter
• Length: 12.5 Millimeter
• Outer Diameter: 5.2 Millimeter
• Length: 12.5 Millimeter
• Outer Diameter: 5.2 Millimeter
• Length: 12.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810157310538 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251938

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-22
• Device Publish Date: 2025-12-12

On-Brand Devices [GEN5+™ Implant]

• 00810157310392: GEN5+ Imp. 3.7mmD-14mmL-3.5mmP
• 00810157310385: GEN5+ Imp. 3.7mmD-12.5mmL-3.5mmP
• 00810157310378: GEN5+ Imp. 3.7mmD-11mmL-3.5mmP
• 00810157310361: GEN5+ Imp. 3.7mmD-9mmL-3.5mmP
• 00810157310354: GEN5+ Imp. 3.7mmD-7mmL-3.5mmP
• 00810157310422: GEN5+ Imp. 4.2mmD-11mmL-3.5mmP
• 00810157310415: GEN5+ Imp. 4.2mmD-9mmL-3.5mmP
• 00810157310408: GEN5+ Imp. 4.2mmD-7mmL-3.5mmP
• 00810157310590: GEN5+ Imp. 5.7mmD-14mmL-4.5mmP
• 00810157310583: GEN5+ Imp. 5.7mmD-12.5mmL-4.5mmP
• 00810157310576: GEN5+ Imp. 5.7mmD-11mmL-4.5mmP
• 00810157310569: GEN5+ Imp. 5.7mmD-9mmL-4.5mmP
• 00810157310552: GEN5+ Imp. 5.7mmD-7mmL-4.5mmP
• 00810157310545: GEN5+ Imp. 5.2mmD-14mmL-4.5mmP
• 00810157310538: GEN5+ Imp. 5.2mmD-12.5mmL-4.5mmP
• 00810157310521: GEN5+ Imp. 5.2mmD-11mmL-4.5mmP
• 00810157310514: GEN5+ Imp. 5.2mmD-9mmL-4.5mmP
• 00810157310507: GEN5+ Imp. 5.2mmD-7mmL-4.5mmP
• 00810157310491: GEN5+ Imp. 4.7mmD-14mmL-4.5mmP
• 00810157310484: GEN5+ Imp. 4.7mmD-12.5mmL-4.5mmP
• 00810157310477: GEN5+ Imp. 4.7mmD-11mmL-4.5mmP
• 00810157310460: GEN5+ Imp. 4.7mmD-9mmL-4.5mmP
• 00810157310453: GEN5+ Imp. 4.7mmD-7mmL-4.5mmP
• 00810157310446: GEN5+ Imp. 4.2mmD-14mmL-3.5mmP
• 00810157310439: GEN5+ Imp. 4.2mmD-12.5mmL-3.5mmP