FDA.reportPublic FDA data

ET Transfer Abutment

Primary DI
00810019243431
Brand
ET Transfer Abutment
Company
HIOSSEN, INC.
Model
ETTA7024SNW
Published
2020-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K182091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182091000Osstem Abutment SystemOsstem Implant Co., Ltd.2019-07-12NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810019243431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810019243431008100192434318100192434310810019243431

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
00814913024219A-Oss®AOSN010SV2016-09-30
00814913024226A-Oss®AOSN025SV2016-09-30
00814913024233A-Oss®AOSN050SV2016-09-30
00814913024240A-Oss®AOSN100SV2016-09-30
00814913024257A-Oss®AOSN200SV2016-09-30
00814913024264A-Oss®AOSN010LV2016-09-30
00814913024271A-Oss®AOSN025LV2016-09-30
00814913024288A-Oss®AOSN050LV2016-09-30
00814913024295A-Oss®AOSN100LV2016-09-30
00814913024301A-Oss®AOSN200LV2016-09-30
00814913024974A-graft®[Bone grafting material,Animal source]HAS010SV2018-04-27
00814913024981A-graft®[Bone grafting material,Animal source]HAS025SV2018-04-27
00814913024998A-graft®[Bone grafting material,Animal source]HAS050SV2018-04-27
00814913025001A-graft®[Bone grafting material,Animal source]HAS100SV2018-04-27
00814913025018A-Oss®A-graft®[Bone grafting material,Animal source]HAS200SV2018-04-27
00814913025025A-graft®[Bone grafting material,Animal source]HAS010LV2018-04-27
00814913025032A-graft®[Bone grafting material,Animal source]HAS025LV2018-04-27
00814913025049A-graft®[Bone grafting material,Animal source]HAS050LV2018-04-27
00814913025056A-graft®[Bone grafting material,Animal source]HAS100LV2018-04-27
00814913025063A-graft®[Bone grafting material,Animal source]HAS200LV2018-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968582008plant Implant System8dent Inc.NHA2026-11-04
088000968584398plant Implant System8dent Inc.NHA2026-11-04
088000968586998plant Implant System8dent Inc.NHA2026-11-04
088000968602108plant Implant System8dent Inc.NHA2026-11-04
088000968602278plant Implant System8dent Inc.NHA2026-11-04
088000968612318plant Implant System8dent Inc.NHA2026-11-04
088000968612488plant Implant System8dent Inc.NHA2026-11-04
088000968622908plant Implant System8dent Inc.NHA2026-11-04
088000968686058plant Implant System8dent Inc.NHA2026-11-04
088000968788578plant Implant System8dent Inc.NHA2026-11-04
00840481137181LOCATOR Angled AbutmentZest Anchors, LLCNHA2026-11-03
08800077020022ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020053ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020640ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020657ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020664ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020671ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020688ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020695ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020701ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020718ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020725ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020732ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020749ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020756ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020763ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020770ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020787ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020794ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30
08800077020800ZEROS Dental Implant SystemZEROS Co., Ltd.NHA2026-10-30