ET Custom Healing Abutment

GUDID 00810019240041

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00810019240041
NIH Device Record Key29dbe3aa-7ca6-456f-b9a3-8d18fb4064d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameET Custom Healing Abutment
Version Model NumberETHLAP5R
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
GS100810019240041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-23
Device Publish Date2019-05-15

On-Brand Devices [ET Custom Healing Abutment ]

00810019240065ETHLAP9R
00810019240058ETHLAP7R
00810019240041ETHLAP5R
00810019240027ETHLAP9M
00810019240010ETHLAP7M
00810019240003ETHLAP5M

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