FDA.reportPublic FDA data

GenTek® Angulated Screw Channel TiBase, Certain® Non-Engaging, 5.0mmD x 0.3mmCH

Primary DI
04251881714944
Brand
GenTek® Angulated Screw Channel TiBase, Certain® Non-Engaging, 5.0mmD x 0.3mmCH
Company
Zfx GmbH
Model
ZFX11ZB-CE50ASZ03N
Published
2024-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231915000Zfx AbutmentsZfx GmbH - A Company of Zimvie2024-03-01NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251881714944PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251881714944042518817149444251881714944

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-342-5454dentalcs@zimvie.com

Regulatory Flags#

DUNS number
340880052
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251881769005GenTek® Scanbody, Certain®, 3.4mmDZFX05Z-ZB-CE-342024-04-11
04251881769029GenTek® Scanbody, Certain®, 4.1mmDZFX05Z-ZB-CE-412024-04-11
04251881769043GenTek® Scanbody, Certain®, 5.0mmDZFX05Z-ZB-CE-502024-04-11
04251881769067GenTek® Scanbody, Certain®, 6.0mmDZFX05Z-ZB-CE-602024-04-11
04251881769081GenTek® Scanbody, External Hex, 3.4mmDZFX05Z-ZB-EX-342024-04-11
04251881769104GenTek® Scanbody, External Hex, 4.1mmDZFX05Z-ZB-EX-412024-04-11
04251881769128GenTek® Scanbody, External Hex, 5.0mmDZFX05Z-ZB-EX-502024-04-11
04251881769142GenTek® Scanbody, External Hex, 6.0mmDZFX05Z-ZB-EX-602024-04-11
04251881769166GenTek® Scanbody, Eztetic®, 2.9mmDZFX05Z-ZB-EZ-292024-04-11
04251881769180GenTek® Scanbody, Low Profile, 4.8mmDZFX05Z-ZB-LP-482024-04-11
04251881769203GenTek® Scanbody, Tapered Abutment, 4.5mmDZFX05Z-ZB-TA-452024-04-11
04251881769227GenTek® Scanbody, TSV®/Trabecular Metal®, 3.5mmDZFX05Z-ZB-TSV-352024-04-11
04251881769241GenTek® Scanbody, TSV®/Trabecular Metal®, 4.5mmDZFX05Z-ZB-TSV-452024-04-11
04251881769265GenTek® Scanbody, TSV®/Trabecular Metal®, 5.7mmDZFX05Z-ZB-TSV-572024-04-11
04251881703504GenTek® Hexed Gold-Tite Screw, Certain®ZFX09-ZB-CE-HGTS2024-03-27
04251881703542GenTek® Large Gold-Tite Screw, Certain®ZFX09-ZB-CE-LGTS2024-03-27
04251881703627GenTek® Retaining Screw, Eztetic®ZFX09-ZB-EZ-RS2024-03-27
04251881703702GenTek® Retaining Screw, TSV®/Trabecular Metal®ZFX09-ZB-TSV-RS2024-03-27
04251881703740GenTek® Gold-Tite® Hexalobular Screw, Certain®, EngagingZFX09-ZB-CE-HLGTE2024-03-27
04251881703764GenTek® Gold-Tite® Hexalobular Screw, Certain®, Non-EngagingZFX09-ZB-CE-HLGTN2024-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMKA03117ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA10503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA20503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA02821ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA10502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA20502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA40502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8509ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851517ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851530ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8515TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS81PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS82PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS83PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC83ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11