Esthetic-low Plastic Cylinder

GUDID 00810019241826

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00810019241826
NIH Device Record Key6594c74f-e12b-4fd9-bcec-a6d6b3958dbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsthetic-low Plastic Cylinder
Version Model NumberETMEPR100TH
Company DUNS796083090
Company NameHIOSSEN, INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810019241826 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-23
Device Publish Date2019-05-15

On-Brand Devices [Esthetic-low Plastic Cylinder]

00810019241833ETMEPW100TH
00810019241826ETMEPR100TH
00810019241819ETMEPW200TH
00810019241802ETMEPR200TH

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