CeraRoot Guided Surgery System 020.02S

GUDID 08435453901093

CeraRoot Guided Surgery System / Convenience kit / procedure pack.

CERAROOT SL.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: 08435453901093
• NIH Device Record Key: e0067abb-e5a5-47a3-ba0e-3f315e8ae095
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CeraRoot Guided Surgery System
• Version Model Number: 020.002S
• Catalog Number: 020.02S
• Company DUNS: 467001948
• Company Name: CERAROOT SL.
• Device Count: 1
• DM Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08435453901093 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

[08435453901093]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-14
• Device Publish Date: 2023-11-06

Devices Manufactured by CERAROOT SL.

• 08435453901086 - CeraRoot Implant System: 2025-05-05 Transporter 11 short - ceramic for the CeraRoot 11 implant
• 08435453901222 - CeraRoot Implant System: 2025-05-05 Implant CeraRoot 12:08/4.1 Size L= 8mm Indicated for UPPER LATERAL INCISORS AND LOWER INCISORS One-piece zirconia dental
• 08435453901093 - CeraRoot Guided Surgery System: 2023-11-14CeraRoot Guided Surgery System / Convenience kit / procedure pack.
• 08435453901093 - CeraRoot Guided Surgery System: 2023-11-14 CeraRoot Guided Surgery System / Convenience kit / procedure pack.
• 08435453900737 - CeraRoot Implant System: 2023-11-10 CeraRoot Guided Surgical Tray (empty). It's used to store all the necessary instruments to perform the dental CeraRoot Guided im
• 08435453900256 - CeraRoot Implant System: 2020-01-09 Twist Drill Triangle Shape to start osteotomy, with laser marks at 6-8-10-12-14-16mm. Made of Steel.
• 08435453900263 - CeraRoot Implant System: 2020-01-09 Twist Drill 2.3mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Steel.
• 08435453900287 - CeraRoot Implant System: 2020-01-09 Twist Drill 3.5mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Steel.
• 08435453900294 - CeraRoot Implant System: 2020-01-09 Twist Drill 4.2mm cylindrical, with laser marks at 6-8-10-12-14-16mm. Made of Steel.