Esthetic-low Temporary Abutment

GUDID 00810019241918

HIOSSEN, INC.

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00810019241918
NIH Device Record Key1e5249e4-bbbd-4a9f-b07c-964e6b3c0af1
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsthetic-low Temporary Abutment
Version Model NumberETNMTW100TH
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
GS100810019241918 [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 Temporary Abutment]

00810019241918ETNMTW100TH
00810019241901ETNMTR100TH
00810019241895ETNMTW200TH
00810019241888ETNMTR200TH
00810019241871ETMTW100TH
00810019241864ETMTR100TH
00810019241857ETMTW200TH
00810019241840ETMTR200TH

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