HG III Fixture RBM Regular No Mount

GUDID 00814913022376

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913022376
NIH Device Record Key6e1ccfcd-f012-43e6-bc69-1cf714271452
Commercial Distribution StatusIn Commercial Distribution
Brand NameHG III Fixture RBM Regular No Mount
Version Model NumberCHG3S5010R
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
GS100814913022376 [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 [HG III Fixture RBM Regular No Mount]

00814913022406CHG3S5015R
00814913022390CHG3S5013R
00814913022383CHG3S5011R
00814913022376CHG3S5010R
00814913022369CHG3S5008R
00814913022352CHG3S5007R
00814913022345CHG3S4515R
00814913022338CHG3S4513R
00814913022321CHG3S4511R
00814913022314CHG3S4510R
00814913022307CHG3S4508R
00814913022291CHG3S4507R
00814913022284CHG3S4015R
00814913022277CHG3S4013R
00814913022260CHG3S4011R
00814913022253CHG3S4010R
00814913022246CHG3S4008R
00814913022239CHG3S4007R

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