HS II Fixture Wide RBM Pre-Mounted

GUDID 00814913023182

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913023182
NIH Device Record Key73104084-3b45-4e19-93c9-ebde61fbd64f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHS II Fixture Wide RBM Pre-Mounted
Version Model NumberAHS2W5013R20
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
GS100814913023182 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-08

On-Brand Devices [HS II Fixture Wide RBM Pre-Mounted]

00814913023199AHS2W5015R20
00814913023182AHS2W5013R20
00814913023175AHS2W5011R20
00814913023168AHS2W5010R20
00814913023151AHS2W5008R20
00814913023144AHS2W5007R20
00814913023137AHS2W4515R20
00814913023120AHS2W4513R20
00814913023113AHS2W4511R20
00814913023106AHS2W4510R20
00814913023090AHS2W4508R20
00814913023083AHS2W4507R20

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