ASC Abutment AS35-ER62

GUDID 00810157310682

ASC Eng Abut, 4.7mmD-2.0mmL-3.5mmP

Paragon Implant Mfg., LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00810157310682
• NIH Device Record Key: 120673ad-d130-41a2-8de8-d50364eed026
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASC Abutment
• Version Model Number: AS35-ER62
• Catalog Number: AS35-ER62
• 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: false
• 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: 4.7 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 2 Millimeter
• Outer Diameter: 4.7 Millimeter
• Length: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810157310682 [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

[00810157310682]

Moist Heat or Steam Sterilization

[00810157310682]

Moist Heat or Steam Sterilization

[00810157310682]

Moist Heat or Steam Sterilization

[00810157310682]

Moist Heat or Steam Sterilization

[00810157310682]

Moist Heat or Steam Sterilization

[00810157310682]

Moist Heat or Steam Sterilization

[00810157310682]

Moist Heat or Steam Sterilization

[00810157310682]

Moist Heat or Steam Sterilization

[00810157310682]

Moist Heat or Steam Sterilization

[00810157310682]

Moist Heat or Steam Sterilization

[00810157310682]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-24
• Device Publish Date: 2025-12-16

On-Brand Devices [ASC Abutment]

• 00810157312426: ASC Eng Abut, 5.7mmD-0.5mmL-4.5mmP
• 00810157310804: ASC Eng Abut, 5.7mmD-2.0mmL-4.5mmP
• 00810157310798: ASC Eng Abut, 5.2mmD-2.0mmL-4.5mmP
• 00810157310781: ASC Eng Abut, 5.2mmD-0.5mmL-4.5mmP
• 00810157310767: ASC Non-Eng Abut, 5.2mmD-2.0mmL-3.5mmP
• 00810157310750: ASC Non-Eng Abut, 5.2mmD-0.5mmL-3.5mmP
• 00810157310743: ASC Non-Eng Abut, 4.7mmD-2.0mmL-3.5mmP
• 00810157310736: ASC Non-Eng Abut, 4.7mmD-0.5mmL-3.5mmP
• 00810157310729: ASC Non-Eng Abut, 3.7mmD-2.0mmL-3.5mmP
• 00810157310712: ASC Non-Eng Abut, 3.7mmD-0.5mmL-3.5mmP
• 00810157310705: ASC Eng Abut, 5.2mmD-2.0mmL-3.5mmP
• 00810157310699: ASC Eng Abut, 5.2mmD-0.5mmL-3.5mmP
• 00810157310682: ASC Eng Abut, 4.7mmD-2.0mmL-3.5mmP
• 00810157310675: ASC Eng Abut, 4.7mmD-0.5mmL-3.5mmP
• 00810157310668: ASC Eng Abut, 3.7mmD-2.0mmL-3.5mmP
• 00810157310651: ASC Eng Abut, 3.7mmD-0.5mmL-3.5mmP
• 00810157310842: ASC Non-Eng Abut, 5.7mmD-2.0mmL-4.5mmP
• 00810157310835: ASC Non-Eng Abut, 5.7mmD-0.5mmL-4.5mmP
• 00810157310828: ASC Non-Eng Abut, 5.2mmD-2.0mmL-4.5mmP
• 00810157310811: ASC Non-Eng Abut, 5.2mmD-0.5mmL-4.5mmP