SELF THREAD/LOGIC PLUS/SPARK PC-T

GUDID 07290110726171

CYLINDER

HI-TEC IMPLANTS LTD.

Dental implant system
Primary Device ID07290110726171
NIH Device Record Keyd10be43f-92bc-4421-8b5f-9aff2731a564
Commercial Distribution StatusIn Commercial Distribution
Brand NameSELF THREAD/LOGIC PLUS/SPARK
Version Model NumberPC-T
Catalog NumberPC-T
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290110726171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-12

On-Brand Devices [SELF THREAD/LOGIC PLUS/SPARK]

07290110728205MODULAR SYSTEM ABUTMENT
07290110728199MODULAR SYSTEM ABUTMENT
07290110728182MODULAR SYSTEM ABUTMENT
07290110728175MODULAR SYSTEM ABUTMENT
07290110727635UNIVERSAL UNIT ANGULATED ABUTMENT
07290110727628UNIVERSAL UNIT ANGULATED ABUTMENT
07290110727611UNIVERSAL UNIT ABUTMENT
07290110727604UNIVERSAL UNIT ABUTMENT
07290110727598UNIVERSAL UNIT ABUTMENT
07290110727581UNIVERSAL UNIT ABUTMENT
07290110727376IMPLANT ANALOG
07290110727017TRANSFER
07290110727000TRANSFER
07290110726997TRANSFER
07290110726980TRANSFER
07290110726768NYLON CAP
07290110726751NYLON CAP
07290110726744NYLON CAP
07290110726737NYLON CAP
07290110726720METAL HOUSING
07290110726713ANALOG
07290110726409BALL-ATTACHMENT ABUTMENT
07290110726393BALL-ATTACHMENT ABUTMENT
07290110726386BALL-ATTACHMENT ABUTMENT
07290110726379BALL-ATTACHMENT ABUTMENT
07290110726270TOOL
07290110726263TOOL
07290110726256ANALOG
07290110726249ANALOG
07290110726232TRANSFER
07290110726225FIXATION SCREW
07290110726218FIXATION SCREW
07290110726201FIXATION SCREW
07290110726195CYLINDER
07290110726188CYLINDER
07290110726171CYLINDER
07290110726164CYLINDER
07290110726157CYLINDER
07290110726096FIXED DETACHABLE ABUTMENT
07290110726089FIXED DETACHABLE ABUTMENT
07290110726072FIXED DETACHABLE ABUTMENT
07290110726065FIXED DETACHABLE ABUTMENT
07290110726058FIXED DETACHABLE ABUTMENT
07290110726041FIXED DETACHABLE ABUTMENT
07290110725792PEEK ANGULATED ABUTMENT
07290110725785PEEK ANGULATED ABUTMENT
07290110725778PEEK ABUTMENT
07290110725600SCAN ABUTMENT
07290110725594SCAN ABUTMENT
07290110725426T-BASE ABUTMENT

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