GEN5™ Implant SP4211

GUDID 00810157310187

GEN5 Imp. 4.2mmD-11mmL-3.5mmP

Paragon Implant Mfg., LLC

Dental implant system

• Primary Device ID: 00810157310187
• NIH Device Record Key: 547a314b-6dde-4807-a0fd-55ada37de43c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEN5™ Implant
• Version Model Number: SP4211
• Catalog Number: SP4211
• 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: 4.2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11 Millimeter
• Outer Diameter: 4.2 Millimeter
• Length: 11 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810157310187 [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]

• 00810157310125: GEN5 Imp. 3.7mmD-7mmL-3.5mmP
• 00810157310200: GEN5 Imp. 4.2mmD-14mmL-3.5mmP
• 00810157310194: GEN5 Imp. 4.2mmD-12.5mmL-3.5mmP
• 00810157310187: GEN5 Imp. 4.2mmD-11mmL-3.5mmP
• 00810157310170: GEN5 Imp. 4.2mmD-9mmL-3.5mmP
• 00810157310163: GEN5 Imp. 4.2mmD-7mmL-3.5mmP
• 00810157310156: GEN5 Imp. 3.7mmD-12.5mmL-3.5mmP
• 00810157310149: GEN5 Imp. 3.7mmD-11mmL-3.5mmP
• 00810157310118: GEN5 Imp. 3.7mmD-14mmL-3.5mmP
• 00810157310040: GEN5 Imp. 3.7mmD-9mmL-3.5mmP
• 00810157310347: GEN5 Imp. 5.7mmD-14mmL-4.5mmP
• 00810157310330: GEN5 Imp. 5.7mmD-12.5mmL-4.5mmP
• 00810157310323: GEN5 Imp. 5.7mmD-11mmL-4.5mmP
• 00810157310316: GEN5 Imp. 5.7mmD-9mmL-4.5mmP
• 00810157310309: GEN5 Imp. 5.7mmD-7mmL-4.5mmP
• 00810157310293: GEN5 Imp. 5.2mmD-14mmL-4.5mmP
• 00810157310286: GEN5 Imp. 5.2mmD-12.5mmL-4.5mmP
• 00810157310279: GEN5 Imp. 5.2mmD-11mmL-4.5mmP
• 00810157310262: GEN5 Imp. 5.2mmD-9mmL-4.5mmP
• 00810157310255: GEN5 Imp. 5.2mmD-7mmL-4.5mmP
• 00810157310248: GEN5 Imp. 4.7mmD-14mmL-4.5mmP
• 00810157310231: GEN5 Imp. 4.7mmD-12.5mmL-4.5mmP
• 00810157310224: GEN5 Imp. 4.7mmD-11mmL-4.5mmP
• 00810157310217: GEN5 Imp. 4.7mmD-7mmL-4.5mmP
• 00810157310132: GEN5 Imp. 4.7mmD-9mmL-4.5mmP