Oral Surgery System

GUDID 04719873120611

BONART CO., LTD.

Dental ultrasonic surgical system
Primary Device ID04719873120611
NIH Device Record Key4a5946e5-f7ff-483f-b3da-001143bd6f73
Commercial Distribution StatusIn Commercial Distribution
Brand NameOral Surgery System
Version Model NumberARTEOTOMY BIS
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
GS104719873120611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDrill, Bone, Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719873120611]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-13

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

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