SS SA Fixture System

GUDID 08800209320679

Osstem Implant Co., Ltd.

Screw endosteal dental implant, two-piece
Primary Device ID08800209320679
NIH Device Record Keyd60884ba-22c7-43b7-9221-63d3dcd1e262
Commercial Distribution StatusIn Commercial Distribution
Brand NameSS SA Fixture System
Version Model NumberSS3R4008S28
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
GS108800209320679 [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 [SS SA Fixture System]

08800209322741SS3W5013S20
08800209322659SS3W5011S20
08800209322567SS3W5010S20
08800209322475SS3W5008S20
08800209322383SS3W5007S20
08800209322291SS3W5006S20
08800209322086SS3W4513S20
08800209321997SS3W4511S20
08800209321904SS3W4510S20
08800209321812SS3W4508S20
08800209321720SS3W4507S20
08800209321201SS3R4513S28
08800209321195SS3R4513S18
08800209321140SS3R4511S28
08800209321133SS3R4511S18
08800209321089SS3R4510S28
08800209321072SS3R4510S18
08800209321027SS3R4508S28
08800209321010SS3R4508S18
08800209320969SS3R4507S18
08800209320853SS3R4013S28
08800209320846SS3R4013S18
08800209320792SS3R4011S28
08800209320785SS3R4011S18
08800209320730SS3R4010S28
08800209320723SS3R4010S18
08800209320679SS3R4008S28
08800209320662SS3R4008S18
08800209320617SS3R4007S18
08800209320495SS3R3513S28
08800209320488SS3R3513S18
08800209320433SS3R3511S28
08800209320426SS3R3511S18
08800209320372SS3R3510S28
08800209320365SS3R3510S18
08800209320310SS3R3508S28
08800209320303SS3R3508S18
08800209319345SS2W5015S20
08800209319253SS2W5013S20
08800209319161SS2W5011S20
08800209319079SS2W5010S20
08800209318980SS2W5008S20
08800209318898SS2W5007S20
08800209318805SS2W5006S20
08800209318539SS2W4515S20
08800209318447SS2W4513S20
08800209318355SS2W4511S20
08800209318263SS2W4510S20
08800209318171SS2W4508S20
08800209318089SS2W4507S20

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