SM3

GUDID 00814913029603

SM3 complete set - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

HIOSSEN, INC.

Dental implant system
Primary Device ID00814913029603
NIH Device Record Key29859777-d8d1-43c3-bd94-f26946528454
Commercial Distribution StatusIn Commercial Distribution
Brand NameSM3
Version Model NumberSM3 120V OPT
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814913029603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBWController, Foot, Handpiece And Cord

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-28
Device Publish Date2021-01-20

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