FDA.reportPublic FDA data

CeraRoot Implant System

Primary DI
08435453900591
Brand
CeraRoot Implant System
Company
CERAROOT SL.
Model
030.005
Catalog number
030.005
Device description
Straumann® Torque Wrench adapter - steel
Published
2019-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08435453900591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435453900591084354539005918435453900591

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench adaptorA component of a surgical wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a variety of distal end pieces (bits). It is intended to be used during an invasive surgical procedure, and is not dedicated to dental use only. It may be referred to as a driver. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
467001948
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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