Esthetic-low Gold Cylinder

GUDID 00810019241796

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00810019241796
NIH Device Record Key76fecfa3-e110-4fa5-a0bc-dc52fcb0d298
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsthetic-low Gold Cylinder
Version Model NumberETMGW200TH
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
GS100810019241796 [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 Gold Cylinder]

00810019241796ETMGW200TH
00810019241789ETMGW100TH
00810019241772ETMGR200TH
00810019241765ETMGR100TH

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