EK Pre-milled Abutment

GUDID 00810126041364

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810126041364
NIH Device Record Key10c1e743-c387-4b68-8bb3-e43577963434
Commercial Distribution StatusIn Commercial Distribution
Brand NameEK Pre-milled Abutment
Version Model NumberEKPMA14CAHT
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810126041364 [Primary]

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-25
Device Publish Date2025-02-17

On-Brand Devices [EK Pre-milled Abutment]

00810126041418EKPMA14ZKNT
00810126041401EKPMA14ZKHT
00810126041395EKPMA14MXNT
00810126041388EKPMA14MXHT
00810126041371EKPMA14CANT
00810126041364EKPMA14CAHT
00810126041357EKPMA14ARNT
00810126041340EKPMA14ARHT
00810126041333EKPMA14ANNT
00810126041326EKPMA14ANHT
00810126041319EKPMA12CENT
00810126041302EKPMA12CEHT
00810126041296EKPMA10ZKNT
00810126041289EKPMA10ZKHT
00810126041272EKPMA10MXNT
00810126041265EKPMA10MXHT
00810126041258EKPMA10CANT
00810126041241EKPMA10CAHT
00810126041234EKPMA10ARNT
00810126041227EKPMA10ARHT
00810126041210EKPMA10ANNT
00810126041203EKPMA10ANHT
00810126041104ETPMA14CARHW

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