SMARTFIT FINAL HYBRID DENTURE -No Hole

Primary DI
00810126043214
Brand
SMARTFIT FINAL HYBRID DENTURE -No Hole
Company
HIOSSEN, INC.
Model
FNLHYD00
Published
2025-07-28
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
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171585000LUXEN Zr, LUXEN SmileDentalmax Co., Ltd.2018-10-31EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810126043214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126043214008101260432148101260432140810126043214

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

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

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
00817724020500Luxisse+HEANY INDUSTRIES, INC.EIH2019-12-23
00817724020326Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020333Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020340Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020357Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020364Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020371Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020388Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020395Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020401Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020418Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020425Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020432Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020449Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020456Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020463Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020470Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020487Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020494Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020036Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020043Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020050Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020067Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020074Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020081Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020098Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020104Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020111Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020128Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020135Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31