HS II Fixture Regular RBM Pre-Mounted

GUDID 00814913022789

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913022789
NIH Device Record Key6bf438b7-6d48-44c6-9ff2-620d2c3c6dee
Commercial Distribution StatusIn Commercial Distribution
Brand NameHS II Fixture Regular RBM Pre-Mounted
Version Model NumberAHS2R4010R18
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
GS100814913022789 [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 Regular RBM Pre-Mounted]

00814913023076AHS2R5015R28
00814913023069AHS2R5015R18
00814913023052AHS2R5013R28
00814913023045AHS2R5013R18
00814913023038AHS2R5011R28
00814913023021AHS2R5011R18
00814913023014AHS2R5010R28
00814913023007AHS2R5010R18
00814913022994AHS2R5008R28
00814913022987AHS2R5008R18
00814913022970AHS2R5007R18
00814913022963AHS2R4515R28
00814913022956AHS2R4515R18
00814913022949AHS2R4513R28
00814913022932AHS2R4513R18
00814913022925AHS2R4511R28
00814913022918AHS2R4511R18
00814913022901AHS2R4510R28
00814913022895AHS2R4510R18
00814913022888AHS2R4508R28
00814913022871AHS2R4508R18
00814913022864AHS2R4507R18
00814913022857AHS2R4015R28
00814913022840AHS2R4015R18
00814913022833AHS2R4013R28
00814913022826AHS2R4013R18
00814913022819AHS2R4011R28
00814913022802AHS2R4011R18
00814913022796AHS2R4010R28
00814913022789AHS2R4010R18
00814913022772AHS2R4008R28
00814913022765AHS2R4008R18
00814913022758AHS2R4007R18

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