ET III Fixture NH Regular No Mount

GUDID 00810126044679

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810126044679
NIH Device Record Key49325160-d819-42a3-9a10-cad78f6b3824
Commercial Distribution StatusIn Commercial Distribution
Brand NameET III Fixture NH Regular No Mount
Version Model NumberCET3R5007B
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
GS100810126044679 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-07
Device Publish Date2025-09-29

On-Brand Devices [ET III Fixture NH Regular No Mount]

00810126044778CET3R5015B
00810126044754CET3R5013B
00810126044730CET3R5011B
00810126044716CET3R5010B
00810126044693CET3R5008B
00810126044679CET3R5007B
00810126044655CET3R5006B
00810126044631CET3R4515B
00810126044617CET3R4513B
00810126044594CET3R4511B
00810126044570CET3R4510B
00810126044556CET3R4508B
00810126044532CET3R4507B
00810126044518CET3R4015B
00810126044495CET3R4013B
00810126044471CET3R4011B
00810126044457CET3R4010B
00810126044433CET3R4008B
00810126044419CET3R4007B

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