FDA.reportPublic FDA data

TITAN IMPLANTS, INC.

Primary DI
00842448109477
Brand
TITAN IMPLANTS, INC.
Company
TITAN IMPLANT INC
Model
T-34IHA-A-4.0
Device description
3.4mm Internal Hex Healing Abutment GH 4mm
Published
2016-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K042971000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042971000TITAN DENTAL IMPLANT SYSTEMTitan Implants, Inc.2005-01-14DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842448109477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842448109477008424481094778424481094770842448109477

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
115545837
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842448116826TITAN IMPLANTS INC.BHI-35IA-AL2026-03-27
00842448115812TITAN IMPLANTS, INC.TS-38FTPME-2.02020-07-14
00842448118547TITAN IMPLANTS INCTIMZ-33IMEFS2026-02-18
00842448118479TITAN IMPLANTS INCH-4-5IA2026-02-17
00842448118486TITAN IMPLANTS INCTIMZ-4IME-4.02026-02-17
00842448118493TITAN IMPLANTS INCTIMZ-4TIE-4.02026-02-17
00842448118509TITAN IMPLANTS INCTIMZ-4TIE-2.02026-02-17
00842448118516TITAN IMPLANTS INCTIMZ-4IME-2.02026-02-17
00842448118424TITAN IMPLANTS INCC-3INTSLIAF-02-1.02026-01-11
00842448118431TITAN IMPLANTS INCSRS-43IA-L2026-01-11
00842448118448TITAN IMPLANTS INCLS-33PA2026-01-11
00842448118455TITAN IMPLANTS INCLS-4PA2026-01-11
00842448118462Titan Implants IncTC-3INTHA-B-3.02026-01-11
00842448118417Titan Implants IncIS-3NNIA-AL2026-01-08
00842448117342TITAN IMPLANTS INCMS-33IIC2026-01-01
00842448117410TITAN IMPLANTS INCDAB-3IIC2026-01-01
00842448117427TITAN IMPLANTS INCDAB-3IA-AL2026-01-01
00842448117519TITAN IMPLANTS INCTTM-4PSH2026-01-01
00842448117656TITAN IMPLANTS INCTN-CM16IAS2026-01-01
00842448117700TITAN IMPLANTS INCTIMZ-4CMIAS22026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878066989NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878066996NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067009NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067016NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067023NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067030NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067047NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067054NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
07899878067061NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-07-03
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08800292991947Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991954Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292991961Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992098Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992104Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992111Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992128Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992135Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992203AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992210AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992227AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992234AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992241AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992258AXA AbutmentMegagen Implant Co. LtdNHA2026-07-03
08800292992265Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992272Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992289AXZAOAS2006Megagen Implant Co. LtdNHA2026-07-03
08800292992296Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03
08800292992302Abutment ScrewMegagen Implant Co. LtdNHA2026-07-03