Cemented Cylinder MCEM 5408N

GUDID 08800049251232

DIO Corporation

Dental implant suprastructure, permanent, preformed
Primary Device ID08800049251232
NIH Device Record Key24f7a7e8-517b-4d95-bcd3-734b02977b68
Commercial Distribution StatusIn Commercial Distribution
Brand NameCemented Cylinder
Version Model NumberMCEM 5408N
Catalog NumberMCEM 5408N
Company DUNS631085206
Company NameDIO Corporation
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800049251232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800049251232]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-18
Device Publish Date2020-03-10

On-Brand Devices [Cemented Cylinder]

08800049251232MCEM 5408N
08800049251225MCEM 5408H

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