EK III NH Fixture Pre-Mounted

GUDID 00810126040046

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810126040046
NIH Device Record Key05db94c5-f266-42d7-b08c-2d8a15917f13
Commercial Distribution StatusIn Commercial Distribution
Brand NameEK III NH Fixture Pre-Mounted
Version Model NumberAEK3S3013B
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
GS100810126040046 [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 Pre-Mounted]

00810019244810AEK3S5013B
00810019244803AEK3S5011B
00810019244797AEK3S5010B
00810019244780AEK3S5008B
00810019244773AEK3S5007B
00810019244766AEK3S4513B
00810019244759AEK3S4511B
00810019244742AEK3S4510B
00810019244735AEK3S4508B
00810019244728AEK3S4507B
00810019244711AEK3S4013B
00810019244704AEK3S4011B
00810019244698AEK3S4010B
00810019244681AEK3S4008B
00810019244674AEK3S4007B
00810019244667AEK3S3513B
00810019244650AEK3S3511B
00810019244643AEK3S3510B
00810019244636AEK3S3508B
00810125997174AEK3S7013B
00810125997167AEK3S7011B
00810125997150AEK3S7010B
00810125997143AEK3S7008B
00810125997136AEK3S7007B
00810125997129AEK3S7006B
00810125997112AEK3S6013B
00810125997105AEK3S6011B
00810125997099AEK3S6010B
00810125997082AEK3S6008B
00810125997075AEK3S6007B
00810125997068AEK3S6006B
00810125997051AEK3S5513B
00810125997044AEK3S5511B
00810125997037AEK3S5510B
00810125997020AEK3S5508B
00810125997013AEK3S5507B
00810125997006AEK3S3013B
00810125996993AEK3S3011B
00810125996986AEK3S3010B
00810125996979AEK3S3008B
00810125996962AEK3S3007B
00810126040169AEK3S7013B
00810126040152AEK3S7011B
00810126040145AEK3S7010B
00810126040138AEK3S7008B
00810126040121AEK3S7007B
00810126040114AEK3S7006B
00810126040107AEK3S6013B
00810126040091AEK3S6011B
00810126040084AEK3S6010B

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