ET3 5.5 NH Pre-mounted

GUDID 00810126043870

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810126043870
NIH Device Record Keybef871d5-f7f9-4474-ab05-762190194eb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameET3 5.5 NH Pre-mounted
Version Model NumberAET3R5507B
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
GS100810126043870 [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 [ET3 5.5 NH Pre-mounted]

00810126043955AET3R5513B
00810126043931AET3R5511B
00810126043917AET3R5510B
00810126043894AET3R5508B
00810126043870AET3R5507B
00810126043856AET3R5506B

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.