FDA.reportPublic FDA data

IU Fixture

Primary DI
08800026100881
Brand
IU Fixture
Company
WARANTEC.Co.,Ltd
Model
FIU40100
Published
2023-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172345000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172345000IU Implant SystemWarantec Co., Ltd.2018-06-18DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800026100881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800026100881088000261008818800026100881

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
688857820
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800026100829IU Fixture FIU360852023-04-12
08800026100836IU Fixture FIU361002023-04-12
08800026100843IU FixtureFIU361152023-04-12
08800026100850IU FixtureFIU361302023-04-12
08800026100867IU FixtureFIU400702023-04-12
08800026100874IU FixtureFIU400852023-04-12
08800026100898IU FixtureFIU401152023-04-12
08800026100904IU FixtureFIU401302023-04-12
08800026100911IU FixtureFIU450702023-04-12
08800026100928IU FixtureFIU450852023-04-12
08800026100935IU FixtureFIU451002023-04-12
08800026100942IU FixtureFIU451152023-04-12
08800026100959IU FixtureFIU451302023-04-12
08800026100966IU FixtureFIU500702023-04-12
08800026100973IU FixtureFIU500852023-04-12
08800026100980IU FixtureFIU501002023-04-12
08800026100997IU FixtureFIU501152023-04-12
08800026101000IU FixtureFIU501302023-04-12
08800026101017IU FixtureFIU550702023-04-12
08800026101024IU FixtureFIU550852023-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806388205226Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205226Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205233Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205233Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205240Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205240Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205257Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205257Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205264Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205264Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205271Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205271Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205288Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205288Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205295Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388205295Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205301Esthetic Healing AbutmentMegagen Implant Co. LtdNHA2021-11-18
08806388205301Esthetic Healing AbutmentMegagen Implant Co. LtdDZE2021-11-18
08806388213023AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213023AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213047AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213047AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213061AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213061AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213085AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213085AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213108AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213108AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18
08806388213122AnyOne External FixtureMegagen Implant Co. LtdNHA2021-11-18
08806388213122AnyOne External FixtureMegagen Implant Co. LtdDZE2021-11-18