FDA.reportPublic FDA data

TITAN IMPLANTS, INC.

Primary DI
00842448106926
Brand
TITAN IMPLANTS, INC.
Company
TITAN IMPLANT INC
Model
S-3FTHA-B-3.0
Device description
3.25mm Flat Top Healing Abutment GH 3mm
Published
2016-12-21
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
00842448106926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842448106926008424481069268424481069260842448106926

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
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
EMKA03117ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA10503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA20503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA02821ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA10502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA20502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA40502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8509ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851517ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851530ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8515TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS81PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS82PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS83PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11