T1-C

GUDID 08800000995793

Osstem Implant Co.,Ltd.

Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital Stationary panoramic/tomographic dental x-ray system, digital
Primary Device ID08800000995793
NIH Device Record Key1ca90504-25ec-4c91-8b96-3e23fb793768
Commercial Distribution StatusIn Commercial Distribution
Brand NameT1-C
Version Model NumberT1-C
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
GS108800000995793 [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.

08800121773621 - HySil Plus Impression Materials2024-02-23
08809917144553 - HySil Plus Impression Materials2023-11-22
08809917144560 - HySil Plus Impression Materials2023-11-22
08809917144577 - HySil Plus Impression Materials2023-11-22
08809917144584 - HySil Plus Impression Materials2023-11-22
08809917144591 - HySil Plus Impression Materials2023-11-22
08809917144607 - HySil Plus Impression Materials2023-11-22
08809917144614 - HySil Plus Impression Materials2023-11-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.