EK III SA Fixture Pre-Mounted

GUDID 00810019245145

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 ID00810019245145
NIH Device Record Key6fc22a70-72ff-4b4c-9e97-29031e5a5372
Commercial Distribution StatusIn Commercial Distribution
Brand NameEK III SA Fixture Pre-Mounted
Version Model NumberAEK3S4513S
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
GS100810019245145 [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 Pre-Mounted]

00810019245190AEK3S5013S
00810019245183AEK3S5011S
00810019245176AEK3S5010S
00810019245169AEK3S5008S
00810019245152AEK3S5007S
00810019245145AEK3S4513S
00810019245138AEK3S4511S
00810019245121AEK3S4510S
00810019245114AEK3S4508S
00810019245107AEK3S4507S
00810019245091AEK3S4013S
00810019245084AEK3S4011S
00810019245077AEK3S4010S
00810019245060AEK3S4008S
00810019245053AEK3S4007S
00810019245046AEK3S3513S
00810019245039AEK3S3511S
00810019245022AEK3S3510S
00810019245015AEK3S3508S
00810125997617AEK3S7013S
00810125997600AEK3S7011S
00810125997594AEK3S7010S
00810125997587AEK3S7008S
00810125997570AEK3S7007S
00810125997563AEK3S7006S
00810125997556AEK3S6013S
00810125997549AEK3S6011S
00810125997532AEK3S6010S
00810125997525AEK3S6008S
00810125997518AEK3S6007S
00810125997501AEK3S6006S
00810125997495AEK3S5513S
00810125997488AEK3S5511S
00810125997471AEK3S5510S
00810125997464AEK3S5508S
00810125997457AEK3S5507S
00810125997440AEK3S3013S
00810125997433AEK3S3011S
00810125997426AEK3S3010S
00810125997419AEK3S3008S
00810125997402AEK3S3007S

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.