HM Implant Narrow Ridge

GUDID 00814913022567

HIOSSEN, INC.

Screw endosteal dental implant, two-piece
Primary Device ID00814913022567
NIH Device Record Key1b18fa16-fb1a-4ca5-99ed-d5888de9522c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHM Implant Narrow Ridge
Version Model NumberHMN2513R04
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
GS100814913022567 [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 [HM Implant Narrow Ridge]

00814913022642HMN3015R04
00814913022635HMN3015R03
00814913022628HMN3013R04
00814913022611HMN3013R03
00814913022604HMN3010R04
00814913022598HMN3010R03
00814913022581HMN2515R04
00814913022574HMN2515R03
00814913022567HMN2513R04
00814913022550HMN2513R03
00814913022543HMN2510R04
00814913022536HMN2510R03

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