HG II Ultra-Wide Fixture RBM Pre-Mounted

GUDID 00814913021492

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913021492
NIH Device Record Keyc0bb1ff1-5b18-4a81-8262-215e2b782ef6
Commercial Distribution StatusIn Commercial Distribution
Brand NameHG II Ultra-Wide Fixture RBM Pre-Mounted
Version Model NumberAHG2S7010R
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
GS100814913021492 [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 II Ultra-Wide Fixture RBM Pre-Mounted]

00814913021515AHG2S7013R
00814913021508AHG2S7011R
00814913021492AHG2S7010R
00814913021485AHG2S7008R
00814913021478AHG2S7007R
00814913021461AHG2S6013R
00814913021454AHG2S6011R
00814913021447AHG2S6010R
00814913021430AHG2S6008R
00814913021423AHG2S6007R

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