FDA.reportPublic FDA data

CeraRoot Guided Surgery System

Primary DI
08435453901093
Brand
CeraRoot Guided Surgery System
Company
CERAROOT SL.
Model
020.002S
Catalog number
020.02S
Device description
CeraRoot Guided Surgery System / Convenience kit / procedure pack.
Published
2023-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435453901093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435453901093084354539010938435453901093

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

Regulatory Flags#

DUNS number
467001948
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
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
08435453900423CeraRoot Implant System004.021004.0212019-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03
07630031778437NAInstitut Straumann AGNDP2026-06-03
07630031778444NAInstitut Straumann AGNDP2026-06-03
07630031778475NAInstitut Straumann AGNDP2026-06-03