CCM Abutment AROCCMNO4111T

GUDID 08806388260065

Ø4/ L=11/ Octa/ NC

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08806388260065
NIH Device Record Key54fe45bb-d339-4219-9518-f21a49b83405
Commercial Distribution StatusIn Commercial Distribution
Brand NameCCM Abutment
Version Model NumberAROCCMNO4111
Catalog NumberAROCCMNO4111T
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
GS108806388260065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806388260065]

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 [CCM Abutment]

08806388211470AnyOne Internal Ø4.5/ Non-Hex
08806388211463AnyOne Internal Ø4.5/ Hex
08806388260096Ø4/ L=11/ Non-Octa/ RC
08806388260089Ø4/ L=11/ Octa/ RC
08806388260072Ø4/ L=11/ Non-Octa/ NC
08806388260065Ø4/ L=11/ Octa/ NC

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