ZENEX MULTI Fixture

GUDID 08800070202609

Izenimplant Co., Ltd.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID08800070202609
NIH Device Record Key70c304eb-3901-495f-bc71-b3fe181cf658
Commercial Distribution StatusIn Commercial Distribution
Brand NameZENEX MULTI Fixture
Version Model NumberZMTW6010
Company DUNS694625347
Company NameIzenimplant Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800070202609 [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 Date2022-05-23
Device Publish Date2022-05-13

On-Brand Devices [ZENEX MULTI Fixture]

08800070201459ZMSM3515
08800070201442ZMSM3513
08800070201435ZMSM3511
08800070201428ZMSM3510
08800070201411ZMSM3508
08800070202685ZMTW7013
08800070202678ZMTW7011
08800070202661ZMTW7010
08800070202654ZMTW7008
08800070202647ZMTW7007
08800070202623ZMTW6013
08800070202616ZMTW6011
08800070202609ZMTW6010
08800070202593ZMTW6008
08800070202586ZMTW6007
08800070202555ZMTW5513
08800070202548ZMTW5511
08800070202531ZMTW5510
08800070202524ZMTW5508
08800070202517ZMTW5507
08800070202494ZMTW5015
08800070202487ZMTW5013
08800070202470ZMTW5011
08800070202463ZMTW5010
08800070202456ZMTW5008
08800070202449ZMTW5007
08800070202425ZMTR4515
08800070202418ZMTR4513
08800070202401ZMTR4511
08800070202395ZMTR4510
08800070202388ZMTR4508
08800070202371ZMTR4507
08800070202364ZMTR4015
08800070202357ZMTR4013
08800070202340ZMTR4011
08800070202333ZMTR4010
08800070202326ZMTR4008
08800070202319ZMTR4007
08800070202302ZMTM3515
08800070202296ZMTM3513
08800070202289ZMTM3511
08800070202272ZMTM3510
08800070202265ZMTM3508
08800070201879ZMSW7013
08800070201862ZMSW7011
08800070201855ZMSW7010
08800070201848ZMSW7008
08800070201831ZMSW7007
08800070201817ZMSW6013
08800070201800ZMSW6011

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