T1-CS

GUDID 08800000995526

Osstem Implant Co.,Ltd.

Stationary panoramic/tomographic dental x-ray system, digital
Primary Device ID08800000995526
NIH Device Record Keyb21b457f-cd0f-40e0-924b-05d791a56390
Commercial Distribution StatusIn Commercial Distribution
Brand NameT1-CS
Version Model NumberT1-CS
Company DUNS694893867
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 Usefalse
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
GS108800000995526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OASX-Ray, Tomography, Computed, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-06
Device Publish Date2021-04-28

Devices Manufactured by Osstem Implant Co.,Ltd.

08800121750769 - Estar-Z2024-09-04
08800121750776 - Estar-Z2024-09-04
08800121750806 - Estar-Z2024-09-04
08800121750837 - Estar-Z2024-09-04
08800121750844 - Estar-Z2024-09-04
08800121750875 - Estar-Z2024-09-04
08800121750882 - Estar-Z2024-09-04
08800121750899 - Estar-Z2024-09-04

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