SS SA Fixture

GUDID 08800040660873

Osstem Implant Co., Ltd.

Screw endosteal dental implant, two-piece
Primary Device ID08800040660873
NIH Device Record Key07c4eb26-c93f-47d5-8130-327dd2b085d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSS SA Fixture
Version Model NumberSS3R4513S28
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
GS108800040660873 [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 Date2022-02-15
Device Publish Date2022-02-07

On-Brand Devices [SS SA Fixture]

08800040662426SS3W5013S20
08800040662334SS3W5011S20
08800040662242SS3W5010S20
08800040662150SS3W5008S20
08800040662068SS3W5007S20
08800040661979SS3W5006S20
08800040661757SS3W4513S20
08800040661665SS3W4511S20
08800040661573SS3W4510S20
08800040661481SS3W4508S20
08800040661399SS3W4507S20
08800040660873SS3R4513S28
08800040660866SS3R4513S18
08800040660811SS3R4511S28
08800040660804SS3R4511S18
08800040660750SS3R4510S28
08800040660743SS3R4510S18
08800040660699SS3R4508S28
08800040660682SS3R4508S18
08800040660637SS3R4507S18
08800040660521SS3R4013S28
08800040660514SS3R4013S18
08800040660460SS3R4011S28
08800040660453SS3R4011S18
08800040660408SS3R4010S28
08800040660392SS3R4010S18
08800040660347SS3R4008S28
08800040660330SS3R4008S18
08800040660286SS3R4007S18
08800040660163SS3R3513S28
08800040660156SS3R3513S18
08800040660101SS3R3511S28
08800040660095SS3R3511S18
08800040660040SS3R3510S28
08800040660033SS3R3510S18
08800040659983SS3R3508S28
08800040659976SS3R3508S18
08800040658481SS2W5013S20
08800040658399SS2W5011S20
08800040658306SS2W5010S20
08800040658214SS2W5008S20
08800040658122SS2W5007S20
08800040658030SS2W5006S20
08800040657781SS2W4515S20
08800040657699SS2W4513S20
08800040657606SS2W4511S20
08800040657514SS2W4510S20
08800040657422SS2W4508S20
08800040657330SS2W4507S20
08800040656746SS2R4515S28

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