Metal Housing MBHR

GUDID 08806388275724

Ø5.0

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08806388275724
NIH Device Record Key6fd1b653-9d3c-49ae-86e5-eb35a48d25f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameMetal Housing
Version Model NumberMBHR
Catalog NumberMBHR
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
GS108806388275724 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806388275724]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-15
Device Publish Date2020-04-07

Devices Manufactured by Megagen Implant Co. Ltd

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08809708751809 - ZrGEN Abutment2025-03-24 Ø4/ C=3/ P=8/ Regular/ Non-Hex
08809708751816 - ZrGEN Abutment2025-03-24 Ø4/ C=4/ P=4.5/ Regular
08809708751823 - ZrGEN Abutment2025-03-24 Ø4/ C=4/ P=4.5/ Regular/ Non-Hex
08806388245437 - ZrGEN Abutment2025-03-14 Ø4.3/ C=1/ S/ C-type
08806388245444 - ZrGEN Abutment2025-03-14 Ø4.3/ C=2/ S/ C-type

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