HG III Fixture RBM Mini Pre-Mounted

GUDID 00814913021874

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913021874
NIH Device Record Key9b0575ac-a787-4919-ae07-225f08479e3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameHG III Fixture RBM Mini Pre-Mounted
Version Model NumberAHG3M3511R
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
GS100814913021874 [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 Date2015-09-02

On-Brand Devices [HG III Fixture RBM Mini Pre-Mounted]

00814913021898AHG3M3515R
00814913021881AHG3M3513R
00814913021874AHG3M3511R
00814913021867AHG3M3510R
00814913021850AHG3M3508R

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.