ET IV Fixture SA Regular Pre-Mounted

GUDID 00814913029207

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913029207
NIH Device Record Key7cdbe12c-3b4c-4f59-af3f-8f51831eda5c
Commercial Distribution StatusIn Commercial Distribution
Brand NameET IV Fixture SA Regular Pre-Mounted
Version Model NumberAET4R4513S
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
GS100814913029207 [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 Date2019-07-18
Device Publish Date2019-07-10

On-Brand Devices [ET IV Fixture SA Regular Pre-Mounted]

00814913029252AET4R5013S
00814913029245AET4R5011S
00814913029238AET4R5010S
00814913029221AET4R5008S
00814913029214AET4R5007S
00814913029207AET4R4513S
00814913029191AET4R4511S
00814913029184AET4R4510S
00814913029177AET4R4508S
00814913029160AET4R4507S
00814913029153AET4R4013S
00814913029146AET4R4011S
00814913029139AET4R4010S
00814913029122AET4R4008S
00814913029115AET4R4007S

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