ULTRASONIC SCALER UNIT

GUDID 04719873120031

BONART CO., LTD.

Ultrasonic dental scaling/debridement system
Primary Device ID04719873120031
NIH Device Record Key97f201d1-fd23-4d17-a5a1-d3d587a15124
Commercial Distribution StatusIn Commercial Distribution
Brand NameULTRASONIC SCALER UNIT
Version Model NumberART-M3II
Company DUNS657263687
Company NameBONART CO., LTD.
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104719873120031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719873120031]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [ULTRASONIC SCALER UNIT]

04719873120031ART-M3II
04719873120024ART-M1

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