ET III Fixture NH Regular No-Mounted

GUDID 00814913023885

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID00814913023885
NIH Device Record Key470a0d06-8091-49f5-b9f4-eb4505bee96b
Commercial Distribution StatusIn Commercial Distribution
Brand NameET III Fixture NH Regular No-Mounted
Version Model NumberCET3R4510B
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
GS100814913023885 [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 No-Mounted]

00814913023977CET3R5015B
00814913023960CET3R5013B
00814913023953CET3R5011B
00814913023946CET3R5010B
00814913023939CET3R5008B
00814913023922CET3R5007B
00814913023915CET3R4515B
00814913023908CET3R4513B
00814913023892CET3R4511B
00814913023885CET3R4510B
00814913023878CET3R4508B
00814913023861CET3R4507B
00814913023854CET3R4015B
00814913023847CET3R4013B
00814913023830CET3R4011B
00814913023823CET3R4010B
00814913023816CET3R4008B
00814913023809CET3R4007B
00814913029627CET3R5006B

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