SELF THREAD /LOGIC PLUS/SPARK ACA-E-2

GUDID 07290110723941

ANTI-ROTATION ABUTMENT

HI-TEC IMPLANTS LTD.

Dental implant suprastructure, permanent, preformed
Primary Device ID07290110723941
NIH Device Record Key5640e53f-e0b9-4958-8c84-91027fff0112
Commercial Distribution StatusIn Commercial Distribution
Brand NameSELF THREAD /LOGIC PLUS/SPARK
Version Model NumberACA-E-2
Catalog NumberACA-E-2
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
GS107290110723941 [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 Number5
Public Version Date2019-11-08
Device Publish Date2017-06-08

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

07290110728564ABUTMENT SCREW
07290110728557ABUTMENT SCREW
07290110728540TRANSFER SCREW
07290110728533TRANSFER SCREW
07290110728526ABUTMENT SCREW
07290110728519ABUTMENT SCREW
07290110728502ABUTMENT SCREW
07290110723996ANTI-ROTATION ABUTMENT
07290110723989ANTI-ROTATION ABUTMENT
07290110723972ANTI-ROTATION ABUTMENT
07290110723965ANTI-ROTATION ABUTMENT
07290110723958ANTI-ROTATION ABUTMENT
07290110723941ANTI-ROTATION ABUTMENT
07290110723934ANTI-ROTATION ABUTMENT
07290110723927ANTI-ROTATION ABUTMENT

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