Meg-Rhein Overdenture System IDR04P

GUDID 08806388220557

Exfeel Internal C=4

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID08806388220557
NIH Device Record Key478ee453-e5fc-4d2d-a68c-cf5743285a99
Commercial Distribution StatusIn Commercial Distribution
Brand NameMeg-Rhein Overdenture System
Version Model NumberIDR04
Catalog NumberIDR04P
Company DUNS687388178
Company NameMegagen 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
GS108806388220557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


[08806388220557]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-09
Device Publish Date2021-07-01

On-Brand Devices [Meg-Rhein Overdenture System]

08806388271191Exfeel Internal C=6
08806388261925Exfeel Internal C=4
08806388261918Exfeel Internal C=0
08806388261901Exfeel Internal C=2
08806388220571Exfeel Internal C=6
08806388220557Exfeel Internal C=4
08806388220533Exfeel Internal C=2
08806388220519Exfeel Internal C=0

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