SMARTbuilder System

GUDID 08800000920979

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000920979
NIH Device Record Keyb44491e7-f293-44fe-9789-fe70e4232878
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMARTbuilder System
Version Model NumberSMHA444
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
GS108800000920979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPlate, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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 [SMARTbuilder System]

08800000920993SMHA443
08800000920986SMHA443R
08800000920979SMHA444
08800000920962SMHA444R
08800000920955SMHA553R
08800000920948SMHA554R
08800000920931SMHA663W
08800000920924SMHA664W
08800000920917SMHA773W
08800000920900SMHA774W
08800000961286SM1W487SB
08800000921143SM1W4107SB
08800000921136SM1W4109SB
08800000921129SM1W487SB
08800000921112SM2W10127SB
08800000921105SM2W10129SB
08800000921099SM2W12127SB
08800000921082SM2W12129SB
08800000921075SM2W797SB
08800000921068SM2W799SB
08800000921051SM3W10127SB
08800000921044SM3W10129SB
08800000921037SM3W12127SB
08800000921020SM3W12129SB
08800000921013SM3W797SB
08800000921006SM3W799SB
08809917096357SMHI420E
08809917096326SMHI415E
08809917096296SMHI410E
08809917096289SMHI405E
08809917096128SMHA554R
08809917096111SMHA553R
08809917096104SMHA444
08809917096098SMHA444R
08809917096081SMHA443
08809917096074SMHA443R

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