Orthodontic Screw System

GUDID 08809917110497

Osstem Implant Co., Ltd.

Screw endosteal dental implant, one-piece
Primary Device ID08809917110497
NIH Device Record Keyba3c5da0-965c-40c9-a634-df1577f1c558
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthodontic Screw System
Version Model NumberOSTH1810
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

Customer Support Contacts

Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809917110497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OATImplant, endosseous, orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-13
Device Publish Date2023-11-04

On-Brand Devices [Orthodontic Screw System]

08809917110497OSTH1810
08809917110459OSTH1808
08809917110411OSTH1806
08809917110374OSTH1610
08809917110329OSTH1608
08809917110244OSTH1606
08809917110169OSTH1408
08809917110114OSTH1406
08809917109835OSSH1810
08809917109798OSSH1808
08809917109750OSSH1806
08809917109705OSSH1610
08809917109668OSSH1608
08809917109620OSSH1606
08809917109576OSSH1408
08809917109552OSSH1406

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