FDA.reportPublic FDA data

Angled Abutment

Primary DI
08800070214770
Brand
Angled Abutment
Company
Izenimplant Co., Ltd.
Model
AASRN57153S
Published
2022-05-10
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
08800070214770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800070214770088000702147708800070214770

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
08800070203156ZENEX MULTI FixtureZMRW70132026-06-04
08800070203217ZENEX MULTI FixtureZMRW50132026-06-04
08800070203224ZENEX MULTI FixtureZMRW50062026-06-04
08800070203231ZENEX MULTI FixtureZMRW50152026-06-04
08800070203248ZENEX MULTI FixtureZMRW55072026-06-04
08800070203255ZENEX MULTI FixtureZMRW55082026-06-04
08800070203262ZENEX MULTI FixtureZMRW55102026-06-04
08800070203279ZENEX MULTI FixtureZMRW55112026-06-04
08800070203286ZENEX MULTI FixtureZMRW55132026-06-04
08800070203293ZENEX MULTI FixtureZMRW55062026-06-04
08800070203309ZENEX MULTI FixtureZMRW55152026-06-04
08800070203316ZENEX MULTI FixtureZMRW60072026-06-04
08800070203323ZENEX MULTI FixtureZMRW60082026-06-04
08800070203330ZENEX MULTI FixtureZMRW60102026-06-04
08800070203347ZENEX MULTI FixtureZMRW60112026-06-04
08800070203354ZENEX MULTI FixtureZMRW60062026-06-04
08800070203361ZENEX MULTI FixtureZMRW60132026-06-04
08800070203378ZENEX MULTI FixtureZMRW70072026-06-04
08800070203385ZENEX MULTI FixtureZMRW70082026-06-04
08800070203392ZENEX MULTI FixtureZMRW70102026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075201041I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075201058I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075201065I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075201072I DoOneday Biotech Co.,Ltd.NHA2026-06-04
08800075202048Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208613Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208620Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208637Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208644Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208651Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208668Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208675Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208682Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208699Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208705Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208712Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208729Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
00842092187661PreatPreat CorporationNHA2026-04-30
00842092187685PreatPreat CorporationNHA2026-04-30
00842092187708PreatPreat CorporationNHA2026-04-30
10841307135647Simply Iconic™ / InterActive™ DIRECTarch™ 3.0mmD Platform Straight MUA 1.5mmL CoIMPLANT DIRECT SYBRON MANUFACTURING LLCNHA2025-10-31
00842092122396Preat Implant ProstheticsPreat CorporationNHA2022-11-22
00842092125632PreatPreat CorporationNHA2022-10-24
00842092125656PreatPreat CorporationNHA2022-10-24
00842092126257PreatPreat CorporationNHA2022-10-24
00842092127001AstraPreat CorporationNHA2022-10-24
00842092127049AstraPreat CorporationNHA2022-10-24
00842092127087AstraPreat CorporationNHA2022-10-24
00842092127094AstraPreat CorporationNHA2022-10-24