ET IV Fixture SA Ultra-Wide Pre-Mounted

GUDID 00814913029351

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913029351
NIH Device Record Key41789abf-548e-498d-884f-39f0169612f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameET IV Fixture SA Ultra-Wide Pre-Mounted
Version Model NumberAET4R7013S
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
GS100814913029351 [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 Ultra-Wide Pre-Mounted]

00814913029351AET4R7013S
00814913029344AET4R7011S
00814913029337AET4R7010S
00814913029320AET4R7008S
00814913029313AET4R7007S
00814913029306AET4R6013S
00814913029290AET4R6011S
00814913029283AET4R6010S
00814913029276AET4R6008S
00814913029269AET4R6007S

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