ET III Fixture NH Regular Pre-Mounted

GUDID 00814913023649

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID00814913023649
NIH Device Record Keyb19a6068-253d-4584-8972-9c24e8e423d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameET III Fixture NH Regular Pre-Mounted
Version Model NumberAET3R4508B
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814913023649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-04

On-Brand Devices [ET III Fixture NH Regular Pre-Mounted]

00814913023748AET3R5015B
00814913023731AET3R5013B
00814913023724AET3R5011B
00814913023717AET3R5010B
00814913023700AET3R5008B
00814913023694AET3R5007B
00814913023687AET3R4515B
00814913023670AET3R4513B
00814913023663AET3R4511B
00814913023656AET3R4510B
00814913023649AET3R4508B
00814913023632AET3R4507B
00814913023625AET3R4015B
00814913023618AET3R4013B
00814913023601AET3R4011B
00814913023595AET3R4010B
00814913023588AET3R4008B
00814913023571AET3R4007B
00814913029610AET3R5006B

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