FDA.reportPublic FDA data

CeraRoot Implant System

Primary DI
08435453900737
Brand
CeraRoot Implant System
Company
CERAROOT SL.
Model
020.002
Catalog number
020.002
Device description
CeraRoot Guided Surgical Tray (empty). It's used to store all the necessary instruments to perform the dental CeraRoot Guided implant surgery. It's made of polymer resistant to dental autoclaves.
Published
2023-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093595000CERAROOT IMPLANT SYSTEMOral Iceberg S.L.2011-01-04DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435453900737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435453900737084354539007378435453900737

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+34937683962info@ceraroot.com
+18184504776usa@ceraroot.com

Regulatory Flags#

DUNS number
467001948
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08435453901116CeraRoot® Implant 16TL, L 8162.008162.0082026-09-22
08435453901123CeraRoot® Implant 16TL, L 10162.010162.0102026-09-22
08435453901130Implant CeraRoot 16TL:12/4.8-6.5162.012162.0122026-09-22
08435453901154CeraRoot® Implant 21TL, L 8212.008212.0082026-09-22
08435453901161CeraRoot® Implant 21TL, L 10212.010212.0102026-09-22
08435453901178CeraRoot® Implant 21TL, L 12212.012212.0122026-09-22
08435453901192CeraRoot® Implant 34TL, L 8342.008342.0082026-09-22
08435453901208CeraRoot® Implant 34TL, L 10342.010342.0102026-09-22
08435453901215CeraRoot® Implant 34TL, L 12342.012342.0122026-09-22
08435453901321CeraRoot® Implant 16TL, L 14162.014162.0142026-09-22
08435453901338CeraRoot® Implant 21TL, L 14212.014212.0142026-09-22
08435453901345CeraRoot® Implant 34TL, L 14342.014342.0142026-09-22
08435453901352Abutment 16TL - 4mm162.104162.1042026-09-22
08435453901369Abutment 16TL - 6mm162.106162.1062026-09-22
08435453901376Abutment 34TL - 4mm342.104342.1042026-09-22
08435453901383Abutment 34TL -6mm342.106342.1062026-09-22
08435453901512Abutment 21TL - 4mm212.104212.1042026-09-22
08435453901529Abutment 21TL -6mm212.106212.1062026-09-22
08435453900515CeraRoot Implant System005.214005.2142019-09-15
08435453901086CeraRoot Implant System006.111006.1112025-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
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07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
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07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14