NP-CAST ABUTMENT SYSTEM

GUDID 08800000921358

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000921358
NIH Device Record Key98378fe9-a340-4bcb-ac5a-31e3f350e41e
Commercial Distribution StatusIn Commercial Distribution
Brand NameNP-CAST ABUTMENT SYSTEM
Version Model NumberHSCNA60WNT
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
GS108800000921358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000921358]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-10-14

On-Brand Devices [NP-CAST ABUTMENT SYSTEM]

08800000921426HSCNA48ROW
08800000921419HSCNA60WOW
08800000921402HSCNA48RNW
08800000921396HSCNA60WNW
08800000921389HSCNA48ROT
08800000921372HSCNA60WOT
08800000921365HSCNA48RNT
08800000921358HSCNA60WNT
08800000921341HGATSM
08800000921334HGATSS
08800000921327CUABSRW
08800000921310CUABSRT

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