FDA.reportPublic FDA data

ET III Fixture SA Regular No Mount

Primary DI
00810126046871
Brand
ET III Fixture SA Regular No Mount
Company
HIOSSEN, INC.
Model
CET3R5018S
Published
2026-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K140934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140934000HIOSSEN IMPLANT SYSTEMHiossen, Inc.2014-11-12DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810126046871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126046871008101260468718101260468710810126046871

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Regulatory Flags#

DUNS number
796083090
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810126045911ET IV Fixture Ultra-Wide NH Regular Pre-MountedAET4R6015B2026-04-10

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
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
08800070229002ZENEX 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