ET II Fixture SA Regular No-Mounted

GUDID 00814913024615

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID00814913024615
NIH Device Record Keyf5d728fb-170c-4061-8ce1-0e2705193a99
Commercial Distribution StatusIn Commercial Distribution
Brand NameET II Fixture SA Regular No-Mounted
Version Model NumberCET2R4013S
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
GS100814913024615 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-17

On-Brand Devices [ET II Fixture SA Regular No-Mounted]

00814913024776CET2R5015S
00814913024769CET2R5013S
00814913024752CET2R5011S
00814913024745CET2R5010S
00814913024738CET2R5008S
00814913024721CET2R5007S
00814913024714CET2R5006S
00814913024691CET2R4515S
00814913024684CET2R4513S
00814913024677CET2R4511S
00814913024660CET2R4510S
00814913024653CET2R4508S
00814913024646CET2R4507S
00814913024639CET2R4018S
00814913024622CET2R4015S
00814913024615CET2R4013S
00814913024608CET2R4011S
00814913024592CET2R4010S
00814913024585CET2R4008S
00814913024578CET2R4007S

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