Milling Abutment (Post type) RSCH719T

GUDID 08809931185846

Rescue External Implant System

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08809931185846
NIH Device Record Key3a43bd02-4bb0-46ee-8328-1e7b39926a92
Commercial Distribution StatusIn Commercial Distribution
Brand NameMilling Abutment (Post type)
Version Model NumberRSCH719
Catalog NumberRSCH719T
Company DUNS687388178
Company NameMegagen Implant Co. Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS108809931185846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


[08809931185846]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-16
Device Publish Date2023-11-08

Devices Manufactured by Megagen Implant Co. Ltd

08809985651175 - ST Internal Fixture2024-09-30 ST Internal System
08809985651182 - ST Internal Fixture2024-09-30 ST Internal Implant System
08809985651199 - ST Internal Fixture2024-09-30 ST Internal Implant System
08809985651205 - ST Internal Fixture2024-09-30 ST Internal Implant System
08809985651212 - ST Internal Fixture2024-09-30 ST Internal Implant System
08809985651229 - ST Internal Fixture2024-09-30 ST Internal Implant System
08809985651236 - ST Internal Fixture2024-09-30 ST Internal Implant System
08809985651243 - ST Internal Fixture2024-09-30 ST Internal Implant System

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