Highness Implant System

GUDID 08800250936546

Non-sterile dental implant abutment intended to connect a dental implant fixture to a prosthetic restoration. Made of titanium alloy with a machined surface

highness Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800250936546
NIH Device Record Key72b5f48c-e068-4f78-b189-e131b6d06984
Commercial Distribution StatusIn Commercial Distribution
Brand NameHighness Implant System
Version Model NumberSLN6524
Company DUNS695930212
Company Namehighness Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800250936546 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-23
Device Publish Date2025-12-15

On-Brand Devices [Highness Implant System]

08800108306361Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08809872389143Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08809872389136Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08809872389129Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08809872389112Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08809872389105Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306439Non-sterile dental implant abutment intended to connect a dental implant fixture to a prosthetic
08800108306354Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306347Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306330Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306323Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306316Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306309Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306293Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306286Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306279Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306262Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306255Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306248Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306231Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306224Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306217Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306200Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306194Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306187Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306170Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306163Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306156Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306149Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306132Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306125Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306118Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306101Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306095Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306088Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306071Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306064Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306057Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306040Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306033Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108306026Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108303711Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108303704Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108303698Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108303681Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108303674Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108303667Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108303650Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108303643Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost
08800108303636Sterile endosseous dental implant intended to replace missing teeth by supporting a dental prost

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