Abutment Screw AROAS16B

GUDID 08806388260508


Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08806388260508
NIH Device Record Keyaf3f1ceb-bcb0-427e-95cd-4f7b3b0dead3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbutment Screw
Version Model NumberAROAS16B
Catalog NumberAROAS16B
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
GS108806388260508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous


Steralize Prior To Usetrue
Device Is Sterilefalse


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

On-Brand Devices [Abutment Screw]

08806388238378Rescue External M2/ Hex
08806388238361ExFeel External M1.4/ Hex
08806388234332ExFeel External M1.6/ Small
08806388231379ExFeel External M2/ Regular, Wide
08806388226412MiNi Internal M1.4
08806388226405MiNi Internal M1.4
08806388225392Rescue External M2.5
08806388222339ExFeel Internal M2
08806388214754EZ Plus Internal M1.6/ Small
08806388211289AnyOne Internal M2
08806388208814Rescue Internal M2.5/ Short
08806388207077EZ Plus Internal M2/ Regular

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