FDA.reportPublic FDA data

CeraRoot Implant System

Primary DI
08435453901222
Brand
CeraRoot Implant System
Company
CERAROOT SL.
Model
120.008
Catalog number
120.008
Device description
Implant CeraRoot 12:08/4.1 Size L= 8mm Indicated for UPPER LATERAL INCISORS AND LOWER INCISORSOne-piece zirconia dental Implant including abutment.
Published
2025-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

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
08435453901222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435453901222084354539012228435453901222

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
467001948
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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