EK III SA Fixture No Mount

GUDID 00810019245268

HIOSSEN, INC.

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece 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 ID00810019245268
NIH Device Record Key5a5d25cc-6fbd-4673-a20c-b123d63eff1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEK III SA Fixture No Mount
Version Model NumberCEK3S4010S
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
GS100810019245268 [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 Date2022-01-21
Device Publish Date2022-01-13

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

00810019245381CEK3S5013S
00810019245367CEK3S5010S
00810019245350CEK3S5008S
00810019245343CEK3S5007S
00810019245336CEK3S4513S
00810019245329CEK3S4511S
00810019245312CEK3S4510S
00810019245305CEK3S4508S
00810019245299CEK3S4507S
00810019245282CEK3S4013S
00810019245275CEK3S4011S
00810019245268CEK3S4010S
00810019245251CEK3S4008S
00810019245244CEK3S4007S
00810019245237CEK3S3513S
00810019245220CEK3S3511S
00810019245213CEK3S3510S
00810019245206CEK3S3508S
00810019245374CEK3S5011S
00810125997839CEK3S7013S
00810125997822CEK3S7011S
00810125997815CEK3S7010S
00810125997808CEK3S7008S
00810125997792CEK3S7007S
00810125997785CEK3S7006S
00810125997778CEK3S6013S
00810125997761CEK3S6011S
00810125997754CEK3S6010S
00810125997747CEK3S6008S
00810125997730CEK3S6007S
00810125997723CEK3S6006S
00810125997716CEK3S5513S
00810125997709CEK3S5511S
00810125997693CEK3S5510S
00810125997686CEK3S5508S
00810125997679CEK3S5507S
00810125997662CEK3S3013S
00810125997655CEK3S3011S
00810125997648CEK3S3010S
00810125997631CEK3S3008S
00810125997624CEK3S3007S

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