ET3 D5.5 SA Pre-mounted

GUDID 00810126043924

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810126043924
NIH Device Record Key606b4e8c-a43c-4d8e-a0d8-07999f460ed6
Commercial Distribution StatusIn Commercial Distribution
Brand NameET3 D5.5 SA Pre-mounted
Version Model NumberAET3R5510S
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
GS100810126043924 [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 D5.5 SA Pre-mounted]

00814913029412AET3R5513S
00814913029405AET3R5511S
00814913029399AET3R5510S
00814913029382AET3R5508S
00814913029375AET3R5507S
00814913029368AET3R5506S
00810126043962AET3R5513S
00810126043948AET3R5511S
00810126043924AET3R5510S
00810126043900AET3R5508S
00810126043887AET3R5507S
00810126043863AET3R5506S

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