Prevest Surgical Guide 3D Printing Resin 18003

GUDID D9671800302

PREVEST DENPRO LIMITED

Dental appliance fabrication material, resin

• Primary Device ID: D9671800302
• NIH Device Record Key: 3c90462a-7f28-4eb1-ac02-e4f1d9ada6fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prevest Surgical Guide 3D Printing Resin
• Version Model Number: 500g plastic bottle
• Catalog Number: 18003
• Company DUNS: 859546940
• Company Name: PREVEST DENPRO LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D9671800302 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09

Devices Manufactured by PREVEST DENPRO LIMITED

• D96710001 - Fusion Bond 7: 2024-05-01
• D96710002 - Fusion Bond 7: 2024-05-01
• D96710003 - Fusion Bond 5: 2024-05-01
• D96710004 - Fusion Bond 5: 2024-05-01
• D96710005 - Fusion Bond DC: 2024-05-01
• D96710016 - Renew MDP: 2024-05-01
• D96710017 - Renew Universal: 2024-05-01
• D96710018 - Renew Universal: 2024-05-01