FDA.reportPublic FDA data

CeraRoot Implant System

Primary DI
08435453900515
Brand
CeraRoot Implant System
Company
CERAROOT SL.
Model
005.214
Catalog number
005.214
Device description
Impactor for implant CeraRoot 14. A metal hand-held manual surgical instrument designed to position the CeraRoot 14 into the alveolar bone. Its mode of application is by transmission of an impact force to drive the implant into its final position in the bone. The proximal end is a handle designed to absorb the impact from a surgical hammer or mallet. The distal end is shaped curved to conform to the implant shape and is made of PEEK. This is a reusable device.
Published
2019-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1
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
08435453900515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435453900515084354539005158435453900515

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactorA metal and/or plastic hand-held manual surgical instrument designed to position an implant into the body. Its mode of application is by transmission of an impact force to drive the implant into its final position in the body. The proximal end is a handle usually designed to absorb the impact from a surgical hammer or mallet. The distal end is usually shaped to conform to the implant shape, which could be flat or anatomically curved, or shaped like a chisel handle to facilitate the positioning. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+18184504776usa@ceraroot.com
+34937683962info@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
08435453901086CeraRoot Implant System006.111006.1112025-04-27
08435453901222CeraRoot Implant System120.008120.0082025-04-27

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
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA451Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA551Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA701Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BONDNG1Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
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
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
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