FDA.reportPublic FDA data

Multi Angled Abutment

Primary DI
08800070222515
Brand
Multi Angled Abutment
Company
Izenimplant Co., Ltd.
Model
MAATRH483050
Published
2022-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

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
K211090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211090000ZENEX Implant SystemIzenimplant Co., Ltd.2022-04-13DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800070222515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070222515088000702225158800070222515

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

Regulatory Flags#

DUNS number
694625347
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800070229125ZENEX MULTI FixtureZMRR4515S2026-06-09
08800070229132ZENEX MULTI FixtureZMRW5007S2026-06-09
08800070229149ZENEX MULTI FixtureZMRW5008S2026-06-09
08800070229156ZENEX MULTI FixtureZMRW5010S2026-06-09
08800070229163ZENEX MULTI FixtureZMRW5011S2026-06-09
08800070229170ZENEX MULTI FixtureZMRW5013S2026-06-09
08800070229187ZENEX MULTI FixtureZMRW5015S2026-06-09
08800070229194ZENEX MULTI FixtureZMRW5507S2026-06-09
08800070229200ZENEX MULTI FixtureZMRW5508S2026-06-09
08800070229217ZENEX MULTI FixtureZMRW5510S2026-06-09
08800070229224ZENEX MULTI FixtureZMRW5511S2026-06-09
08800070229231ZENEX MULTI FixtureZMRW5513S2026-06-09
08800070229248ZENEX MULTI FixtureZMRW5515S2026-06-09
08800070229255ZENEX MULTI FixtureZMRW6007S2026-06-09
08800070229262ZENEX MULTI FixtureZMRW6008S2026-06-09
08800070229279ZENEX MULTI FixtureZMRW6010S2026-06-09
08800070229286ZENEX MULTI FixtureZMRW6011S2026-06-09
08800070229293ZENEX MULTI FixtureZMRW6013S2026-06-09
08800070229309ZENEX MULTI FixtureZMRW7007S2026-06-09
08800070229316ZENEX MULTI FixtureZMRW7008S2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878066989NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878066996NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067009NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067016NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067023NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067030NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067047NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067054NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067061NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
08800292991923Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991930Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991947Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991954Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991961Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992098Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992104Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992111Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992128Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992135Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992203AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992210AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992227AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992234AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992241AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992258AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992265Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992272Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992289AXZAOAS2006Megagen Implant Co. LtdNHA2026-07-03
08800292992296Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992302Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03