FDA.reportPublic FDA data

ETIII SA (Ø3.2mm) Pre-mounted

Primary DI
00810126043269
Brand
ETIII SA (Ø3.2mm) Pre-mounted
Company
HIOSSEN, INC.
Model
AET3M3010S
Published
2025-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K153332000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153332000ETIII SA Fixture System (O3.2mm)Hiossen, Inc.2016-10-27DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810126043269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126043269008101260432698101260432690810126043269

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796083090
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126046888EK MULTI ANGLED ABUTMENTEK17MUA482TH2026-07-31
00810126046895EK MULTI ANGLED ABUTMENTEK17MUA484TH2026-07-31
00810126046901EK MULTI ANGLED ABUTMENTEK17MUA484TH2026-07-31
00810126046918EK MULTI ANGLED ABUTMENTEK30MUA483TH2026-07-31
00810126046925EK MULTI ANGLED ABUTMENTEK30MUA484TH2026-07-31
00810126046932EK MULTI ANGLED ABUTMENTEK30MUA485TH2026-07-31
00810126046949EK MULTI ANGLED ABUTMENTET17MUA482MWH2026-07-31
00810126046956EK MULTI ANGLED ABUTMENTET17MUA482RWH2026-07-31
00810126046963EK MULTI ANGLED ABUTMENTET17MUA483MWH2026-07-31
00810126046970EK MULTI ANGLED ABUTMENTET17MUA483RWH2026-07-31
00810126046987EK MULTI ANGLED ABUTMENTET17MUA484MWH2026-07-31
00810126046994EK MULTI ANGLED ABUTMENTET17MUA484RWH2026-07-31
00810126047007EK MULTI ANGLED ABUTMENTET17MUA485RWH2026-07-31
00810126047014EK MULTI ANGLED ABUTMENTET30MUA483MWH2026-07-31
00810126047021EK MULTI ANGLED ABUTMENTET30MUA483RWH2026-07-31
00810126047038EK MULTI ANGLED ABUTMENTET30MUA484MWH2026-07-31
00810126047045EK MULTI ANGLED ABUTMENTET30MUA484RWH2026-07-31
00810126047052EK MULTI ANGLED ABUTMENTET30MUA485MWH2026-07-31
00810126047069EK MULTI ANGLED ABUTMENTET30MUA485RWH2026-07-31
00810126046871ET III Fixture SA Regular No MountCET3R5018S2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800070230008ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-07-29
08800070201619ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070218600ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070218891ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
08800070228333ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-07-27
00810126046871ET III Fixture SA Regular No MountHIOSSEN, INC.DZE2026-07-14
07290112780010Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780522Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780645Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112780652Dynamix Hex (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781215Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781222Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781246Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781260Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781284Saturn (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781710Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290112781727Dynamix Hex (Premium)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
07290114710565AbutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-07-12
08800070203415ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203422ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203439ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203446ZENEX PLUS FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228951ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228968ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228975ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228982ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070228999ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26
08800070203354ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-26