Multi Angled Abutment system

GUDID 08800000925295

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000925295
NIH Device Record Key214bb7ff-adf7-40d0-bc35-684036d2d39d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti Angled Abutment system
Version Model NumberHGMAA217SHW
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 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
GS108800000925295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000925295]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-10-16

On-Brand Devices [Multi Angled Abutment system]

08800000925370HGMATSM
08800000925363HGMATSS
08800000925356HGMAA217MHW
08800000925349HGMAA317MHW
08800000925332HGMAA417MHW
08800000925325HGMAA330MHW
08800000925318HGMAA430MHW
08800000925301HGMAA530MHW
08800000925295HGMAA217SHW
08800000925288HGMAA317SHW
08800000925271HGMAA417SHW
08800000925264HGMAA330SHW
08800000925257HGMAA430SHW
08800000925240HGMAA530SHW

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