US SA Implant System

GUDID 08800209309070

Osstem Implant Co., Ltd.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID08800209309070
NIH Device Record Key31c8fee4-895c-4920-8f53-c109e8f38349
Commercial Distribution StatusIn Commercial Distribution
Brand NameUS SA Implant System
Version Model NumberAUS3W5010S
Company DUNS689051793
Company NameOsstem Implant Co., 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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800209309070 [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 Date2022-09-06
Device Publish Date2022-08-29

On-Brand Devices [US SA Implant System]

08800040671381US3W5015S
08800040671350US3W5013S
08800040671329US3W5011S
08800040671299US3W5010S
08800040671268US3W5008S
08800040671237US3W5007S
08800040671084US3R4515S
08800040671053US3R4513S
08800040671022US3R4511S
08800040670995US3R4510S
08800040670964US3R4508S
08800040670933US3R4507S
08800040670803US3R4011S
08800040670773US3R4010S
08800040670742US3R4008S
08800040670711US3R4007S
08800040670568US3P5013S
08800040670537US3P5011S
08800040670506US3P5010S
08800040670476US3P5008S
08800040670445US3P5007S
08800040670308US3M3515S
08800040670278US3M3513S
08800040670247US3M3511S
08800040670216US3M3510S
08800040670186US3M3508S
08800040670018US2W5015S
08800040669999US2W5013S
08800040669968US2W5011S
08800040669937US2W5010S
08800040669906US2W5008S
08800040669876US2W5007S
08800040669821US2R4515S
08800040669807US2R4513S
08800040669777US2R4511S
08800040669746US2R4510S
08800040669715US2R4508S
08800040669692US2R4507S
08800040669661US2R4015S
08800040669647US2R4013S
08800040669616US2R4011S
08800040669586US2R4010S
08800040669562US2R4008S
08800040669548US2R4007S
08800040669517US2P5015S
08800040669494US2P5013S
08800040669463US2P5011S
08800040669432US2P5010S
08800040669401US2P5008S
08800040669371US2P5007S

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