FDA.reportPublic FDA data

HI-TEC IMPLANTS

Primary DI
07290110729387
Brand
HI-TEC IMPLANTS
Company
HI-TEC IMPLANTS LTD.
Model
N-HC-4.5-4.5
Catalog number
N-HC-4.5-4.5
Device description
HEALING CAP
Published
2024-12-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
K941575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941575000SMOOTH FITHi-Tec Implants1994-11-17DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290110729387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290110729387072901107293877290110729387

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
600710917
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
07290110729240HI-TEC IMPLANTSN-BBA-3N-BBA-32024-12-16
07290110729257HI-TEC IMPLANTSN-BBA-4N-BBA-42024-12-16
07290110729264HI-TEC IMPLANTSN-BBA-5N-BBA-52024-12-16
07290110729288HI-TEC IMPLANTSN-MU-1N-MU-12024-12-16
07290110729295HI-TEC IMPLANTSN-MU-2N-MU-22024-12-16
07290110729301HI-TEC IMPLANTSN-MU-3N-MU-32024-12-16
07290110729318HI-TEC IMPLANTSN-MU-4N-MU-42024-12-16
07290110729325HI-TEC IMPLANTSN-MU-17N-MU-172024-12-16
07290110729332HI-TEC IMPLANTSN-MU-30N-MU-302024-12-16
07290110729158HI-TEC IMPLANTSN-AATN-AAT2024-12-15
07290110729165HI-TEC IMPLANTSN-AAT-LN-AAT-L2024-12-15
07290110729172HI-TEC IMPLANTSN-ACA-1.5N-ACA-1.52024-12-15
07290110729189HI-TEC IMPLANTSN-ACA-2.5N-ACA-2.52024-12-15
07290110729196HI-TEC IMPLANTSN-ACA-3.5N-ACA-3.52024-12-15
07290110729202HI-TEC IMPLANTSN-ACA-4.5N-ACA-4.52024-12-15
07290110729219HI-TEC IMPLANTSN-ACA-PN-ACA-P2024-12-15
07290110729226HI-TEC IMPLANTSN-ANA-17-1.5N-ANA-17-1.52024-12-15
07290110729233HI-TEC IMPLANTSN-BBA-2N-BBA-22024-12-15
07290110729370HI-TEC IMPLANTSN-HC-4.5-3N-HC-4.5-32024-12-15
07290110729394HI-TEC IMPLANTSN-HC-4.5-6N-HC-4.5-62024-12-15

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