ET III Fixture SA Regular Pre-Mounted

GUDID 00814913020624

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID00814913020624
NIH Device Record Key6e3add2f-7f97-4258-867b-6293b21526bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameET III Fixture SA Regular Pre-Mounted
Version Model NumberAET3R4007S
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
GS100814913020624 [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 III Fixture SA Regular Pre-Mounted]

00814913020839AET3R5018S
00814913020822AET3R5015S
00814913020815AET3R5013S
00814913020808AET3R5011S
00814913020792AET3R5010S
00814913020785AET3R5008S
00814913020778AET3R5007S
00814913020754AET3R4518S
00814913020747AET3R4515S
00814913020730AET3R4513S
00814913020723AET3R4511S
00814913020716AET3R4510S
00814913020709AET3R4508S
00814913020693AET3R4507S
00814913020686AET3R4018S
00814913020679AET3R4015S
00814913020662AET3R4013S
00814913020655AET3R4011S
00814913020648AET3R4010S
00814913020631AET3R4008S
00814913020624AET3R4007S

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