ET II Fixture SA Regular Pre-Mounted

GUDID 00814913020471

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID00814913020471
NIH Device Record Keyb2e3a5df-9cfe-4b61-9eaf-db82478ff91a
Commercial Distribution StatusIn Commercial Distribution
Brand NameET II Fixture SA Regular Pre-Mounted
Version Model NumberAET2R5011S
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
GS100814913020471 [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 Date2015-09-01

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

00814913020501AET2R5018S
00814913020495AET2R5015S
00814913020488AET2R5013S
00814913020471AET2R5011S
00814913020464AET2R5010S
00814913020457AET2R5008S
00814913020440AET2R5007S
00814913020426AET2R4518S
00814913020419AET2R4515S
00814913020402AET2R4513S
00814913020396AET2R4511S
00814913020389AET2R4510S
00814913020372AET2R4508S
00814913020365AET2R4507S
00814913020358AET2R4018S
00814913020341AET2R4015S
00814913020334AET2R4013S
00814913020327AET2R4011S
00814913020310AET2R4010S
00814913020303AET2R4008S
00814913020297AET2R4007S

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