HI-TEC IMPLANTS NPI 4.3-16

GUDID 07290110729097

DENTAL IMPLANT

HI-TEC IMPLANTS LTD.

Screw endosteal dental implant, two-piece
Primary Device ID07290110729097
NIH Device Record Keye3fe6be2-9799-43ce-b6b7-8e36f2dbd1df
Commercial Distribution StatusIn Commercial Distribution
Brand NameHI-TEC IMPLANTS
Version Model NumberNPI 4.3-16mm
Catalog NumberNPI 4.3-16
Company DUNS600710917
Company NameHI-TEC IMPLANTS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110729097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-06
Device Publish Date2024-11-28

On-Brand Devices [HI-TEC IMPLANTS]

07290110729141DENTAL IMPLANT
07290110729134DENTAL IMPLANT
07290110729127DENTAL IMPLANT
07290110729110DENTAL IMPLANT
07290110729103DENTAL IMPLANT
07290110729097DENTAL IMPLANT
07290110729080DENTAL IMPLANT
07290110729073DENTAL IMPLANT
07290110729066DENTAL IMPLANT
07290110729059DENTAL IMPLANT
07290110729042DENTAL IMPLANT
07290110729035DENTAL IMPLANT
07290110729028DENTAL IMPLANT
07290110729011DENTAL IMPLANT
07290110729004DENTAL IMPLANT
07290110729394HEALING CAP
07290110729387HEALING CAP
07290110729370HEALING CAP
07290110729363HEALING CAP
07290110729356HEALING CAP
07290110729233BALL-ATTACHMENT ABUTMENT
07290110729226ANGULATED ABUTMENT
07290110729219ANTIROTATION ABUTMENT
07290110729202ANTIROTATION ABUTMENT
07290110729196ANTIROTATION ABUTMENT
07290110729189ANTIROTATION ABUTMENT
07290110729172ANTIROTATION ABUTMENT
07290110729165TRANSFER
07290110729158TRANSFER
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