FDA.reportPublic FDA data

Cemented Abutment

Primary DI
08800070206638
Brand
Cemented Abutment
Company
Izenimplant Co., Ltd.
Model
CASRN65104
Published
2022-05-17
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
08800070206638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070206638088000702066388800070206638

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
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
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04260516873079SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516873338SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516873352SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873369SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516873628SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874465SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874472SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516874540SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516874557SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516874809SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516874830SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08