EK III NH Fixture No Mount

GUDID 00810126040275

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810126040275
NIH Device Record Keyc94c8df4-5d28-4b4b-8812-754a6ee49827
Commercial Distribution StatusIn Commercial Distribution
Brand NameEK III NH Fixture No Mount
Version Model NumberCEK3S6013B
Company DUNS796083090
Company NameHIOSSEN, INC.
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 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
GS100810126040275 [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 Date2024-09-26
Device Publish Date2024-09-18

On-Brand Devices [EK III NH Fixture No Mount]

00810019245008CEK3S5013B
00810019244995CEK3S5011B
00810019244988CEK3S5010B
00810019244971CEK3S5008B
00810019244964CEK3S5007B
00810019244957CEK3S4513B
00810019244940CEK3S4511B
00810019244933CEK3S4510B
00810019244926CEK3S4508B
00810019244919CEK3S4507B
00810019244902CEK3S4013B
00810019244896CEK3S4011B
00810019244889CEK3S4010B
00810019244872CEK3S4008B
00810019244865CEK3S4007B
00810019244858CEK3S3513B
00810019244841CEK3S3511B
00810019244827CEK3S3508B
00810019244834CEK3S3510B
00810125997396CEK3S7013B
00810125997389CEK3S7011B
00810125997372CEK3S7010B
00810125997365CEK3S7008B
00810125997358CEK3S7007B
00810125997341CEK3S7006B
00810125997334CEK3S6013B
00810125997327CEK3S6011B
00810125997310CEK3S6010B
00810125997303CEK3S6008B
00810125997297CEK3S6007B
00810125997280CEK3S6006B
00810125997273CEK3S5513B
00810125997266CEK3S5511B
00810125997259CEK3S5510B
00810125997242CEK3S5508B
00810125997235CEK3S5507B
00810125997228CEK3S3013B
00810125997211CEK3S3011B
00810125997204CEK3S3010B
00810125997198CEK3S3008B
00810125997181CEK3S3007B
00810126040336CEK3S7013B
00810126040329CEK3S7011B
00810126040312CEK3S7010B
00810126040305CEK3S7008B
00810126040299CEK3S7007B
00810126040282CEK3S7006B
00810126040275CEK3S6013B
00810126040268CEK3S6011B
00810126040251CEK3S6010B

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