AbutmentScrew AROAS16

GUDID 08806388260515

M1.6

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08806388260515
NIH Device Record Key60208503-a066-458d-9b1f-3f17b85135cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbutmentScrew
Version Model NumberAROAS16
Catalog NumberAROAS16
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
GS108806388260515 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806388260515]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-27
Device Publish Date2019-11-19

Devices Manufactured by Megagen Implant Co. Ltd

08806388240128 - Straight Drill2020-01-09 MegaFix Ø4.9/ L=18.5
08806388234912 - Stopper Drill2020-01-09 AnyOne Internal Ø4.8/ L=11.5/ Medium
08806388212545 - Stopper Drill2020-01-09 AnyRidge Internal Ø5.4/ L=13
08806388240111 - Straight Drill2020-01-09 MegaFix Ø4.4/ L=18.5
08806388234905 - Stopper Drill2020-01-09 AnyOne Internal Ø4.8/ L=10/ Medium
08806388212538 - Stopper Drill2020-01-09 AnyRidge Internal Ø5.4/ L=11.5
08806388240104 - Straight Drill2020-01-09 MegaFix Ø3.9/ L=18.5
08806388234899 - Stopper Drill2020-01-09 AnyOne Internal Ø4.8/ L=8.5/ Medium

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