TS Implant System

GUDID 08800000921204

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800000921204
NIH Device Record Keya0ef8cf4-c2d2-4746-995d-9f5a89b1ce48
Commercial Distribution StatusIn Commercial Distribution
Brand NameTS Implant System
Version Model NumberHGQTA553RHT
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
GS108800000921204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800000921204]

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 [TS Implant System]

08800000921242HGQTA453MHT
08800000921235HGQTA453MNT
08800000921228HGQTA455MHT
08800000921211HGQTA455MNT
08800000921204HGQTA553RHT
08800000921198HGQTA553RNT
08800000921181HGQTA555RHT
08800000921174HGQTA555RNT
08800000921167HGATSMT
08800000921150HGATSST

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