M3II TRANSFORMER -115V

GUDID 04719873120970

BONART CO., LTD.

Ultrasonic dental scaling/debridement system
Primary Device ID04719873120970
NIH Device Record Keyfe5faab0-6fae-43dc-869b-a0189fc69da1
Commercial Distribution StatusIn Commercial Distribution
Brand NameM3II TRANSFORMER -115V
Version Model NumberGP0006-291R
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS104719873120970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-15

Devices Manufactured by BONART CO., LTD.

04719873121533 - ART TRIPLE BEND 25kHz2023-04-03
04719873121540 - ART TRIPLE BEND 30kHz2023-04-03
04719873121410 - PIEZO TIP/BE-P2022-03-28
04719873121366 - 25K FS-SLIM PLASTIC INSERT/Darby2021-01-04
04719873121373 - 30K FS-SLIM PLASTIC INSERT/Darby2021-01-04
04719873121380 - 25K FS-10 PLASTIC INSERT/Darby2021-01-04
04719873121397 - 30K FS-10 PLASTIC INSERT/Darby2021-01-04
04719873121359 - BONE TIP/BM-PS12020-09-25

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