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
08435453900515CeraRoot Implant System005.214005.2142019-09-15
08435453901086CeraRoot Implant System006.111006.1112025-04-27
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
08435453900423CeraRoot Implant System004.021004.0212019-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070203156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
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08800070203231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
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08800070203262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
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08800070203354ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
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08800070203378ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
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08800070203392ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
08800070203408ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-04
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