FDA.reportPublic FDA data

CeraRoot Implant System

Primary DI
08435453900461
Brand
CeraRoot Implant System
Company
CERAROOT SL.
Model
005.011
Catalog number
005.011
Device description
Transporter 11 - steel for the CeraRoot 11 implant
Published
2019-09-14
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
08435453900461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435453900461084354539004618435453900461

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter6.5Millimeter

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
08435453900515CeraRoot Implant System005.214005.2142019-09-15
08435453901086CeraRoot Implant System006.111006.1112025-04-27
08435453901222CeraRoot Implant System120.008120.0082025-04-27
08435453901093CeraRoot Guided Surgery System020.002S020.02S2023-11-06
08435453900737CeraRoot Implant System020.002020.0022023-11-02
08435453900355CeraRoot Implant System001.007001.0072019-09-14
08435453900256CeraRoot Implant System001.001001.0012019-08-29
08435453900263CeraRoot Implant System001.002001.0022019-08-29
08435453900287CeraRoot Implant System001.004001.0042019-09-14
08435453900294CeraRoot Implant System001.005001.0052019-09-14
08435453900300CeraRoot Implant System002.002002.0022019-09-14
08435453900317CeraRoot Implant System002.003002.0032019-09-14
08435453900324CeraRoot Implant System002.004002.0042019-09-14
08435453900331CeraRoot Implant System002.005002.0052019-09-14
08435453900362CeraRoot Implant System003.016003.0162019-09-14
08435453900379CeraRoot Implant System003.011003.0112019-09-14
08435453900386CeraRoot Implant System003.021003.0212019-09-14
08435453900393CeraRoot Implant System003.014003.0142019-09-14
08435453900409CeraRoot Implant System004.016004.0162019-09-14
08435453900416CeraRoot Implant System004.011004.0112019-09-14

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Primary DI, Brand, Company table
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