Flat Lab Analog FLA3512

GUDID 08806388218882

AnyOne Internal Ø3.5/ L=12

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08806388218882
NIH Device Record Keyc560a054-a6e2-4f64-9814-cf76bb8b203d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlat Lab Analog
Version Model NumberFLA3512
Catalog NumberFLA3512
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
GS108806388218882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806388218882]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2015-06-24

Devices Manufactured by Megagen Implant Co. Ltd

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08809822762019 - TiGEN Abutment2024-02-28 ARi ExCon Implant System
08809822762101 - ZrGEN Abutment2024-02-28 ARi ExCon Implant System
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