ZENEX PLUS Fixture

GUDID 08800070202883

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 ID08800070202883
NIH Device Record Keyfb6f2599-0b7d-4fe0-bcb1-248db968a11b
Commercial Distribution StatusIn Commercial Distribution
Brand NameZENEX PLUS Fixture
Version Model NumberZPTW5010
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
GS108800070202883 [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 PLUS Fixture]

08800070202968ZPTW5513
08800070202951ZPTW5511
08800070202944ZPTW5510
08800070202937ZPTW5508
08800070202920ZPTW5507
08800070202913ZPTW5015
08800070202906ZPTW5013
08800070202890ZPTW5011
08800070202883ZPTW5010
08800070202876ZPTW5008
08800070202869ZPTW5007
08800070202852ZPTR4515
08800070202845ZPTR4513
08800070202838ZPTR4511
08800070202821ZPTR4510
08800070202814ZPTR4508
08800070202807ZPTR4507
08800070202791ZPTR4015
08800070202784ZPTR4013
08800070202777ZPTR4011
08800070202760ZPTR4010
08800070202753ZPTR4008
08800070202746ZPTR4007
08800070202739ZPTM3515
08800070202722ZPTM3513
08800070202715ZPTM3511
08800070202708ZPTM3510
08800070202692ZPTM3508
08800070202241ZPSW5513
08800070202234ZPSW5511
08800070202227ZPSW5510
08800070202210ZPSW5508
08800070202203ZPSW5507
08800070202197ZPSW5015
08800070202180ZPSW5013
08800070202173ZPSW5011
08800070202166ZPSW5010
08800070202159ZPSW5008
08800070202142ZPSW5007
08800070202111ZPSR4515
08800070202104ZPSR4513
08800070202098ZPSR4511
08800070202081ZPSR4510
08800070202074ZPSR4508
08800070202067ZPSR4507
08800070202036ZPSR4015
08800070202029ZPSR4013
08800070202012ZPSR4011
08800070202005ZPSR4010
08800070201992ZPSR4008

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