PEEK Temporary Abutment PA35-ER

GUDID 00810157311900

PEEK Eng. Temp. Abut, 4.7mmD-3.5mmP

Paragon Implant Mfg., LLC

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00810157311900
• NIH Device Record Key: 2f0f3158-c8dd-42d4-b2ed-d91817f550d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEEK Temporary Abutment
• Version Model Number: PA35-ER
• Catalog Number: PA35-ER
• Company DUNS: 118698566
• Company Name: Paragon Implant Mfg., LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Dimensions

• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 9.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810157311900 [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

[00810157311900]

Moist Heat or Steam Sterilization

[00810157311900]

Moist Heat or Steam Sterilization

[00810157311900]

Moist Heat or Steam Sterilization

[00810157311900]

Moist Heat or Steam Sterilization

[00810157311900]

Moist Heat or Steam Sterilization

[00810157311900]

Moist Heat or Steam Sterilization

[00810157311900]

Moist Heat or Steam Sterilization

[00810157311900]

Moist Heat or Steam Sterilization

[00810157311900]

Moist Heat or Steam Sterilization

[00810157311900]

Moist Heat or Steam Sterilization

[00810157311900]

Moist Heat or Steam Sterilization

[00810157311900]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-16
• Device Publish Date: 2026-01-08

On-Brand Devices [PEEK Temporary Abutment]

• 00810157311917: PEEK Eng. Temp. Abut, 5.7mmD-4.5mmP
• 00810157311900: PEEK Eng. Temp. Abut, 4.7mmD-3.5mmP