27132

GUDID 04963931271320

The device is an instrument used when treating patients with reinfected root canal to remove gutta percha, etc. attached to the root canal walls.

YDM CORPORATION

Manual dental scaler, reusable
Primary Device ID04963931271320
NIH Device Record Keye776760b-e9be-41fb-8fd4-972d12bbc137
Commercial Distribution StatusIn Commercial Distribution
Version Model Number27132
Catalog Number27132
Company DUNS716059766
Company NameYDM CORPORATION
Device Count1
DM Exempttrue
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp
Phone+819019940653
Emailjumpei@ydm.co.jp

Device Identifiers

Device Issuing AgencyDevice ID
GS104963931271320 [Primary]

FDA Product Code

EMNScaler, Periodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


[04963931271320]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-16
Device Publish Date2024-02-08

Devices Manufactured by YDM CORPORATION

04963931227211 - NA2024-04-09 Use to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure.
04963931227228 - NA2024-04-09 Use to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure.
04963931227266 - NA2024-04-09 Use to retract the lips/cheeks of a patient during an orthodontic or restorative dental procedure.
04963931276103 - NA2024-04-09 The intended medical indication is to use to hold or to fix or to remove small objects or to bend or to cut metal strips or wire
04963931102013 - NA2024-02-16 This device is a handle for attaching the working end of dental medical devices manufactured by YDM.
04963931102020 - NA2024-02-16 This device is a handle for attaching the working end of dental medical devices manufactured by YDM.
04963931102037 - NA2024-02-16 This device is a handle for attaching the working end of dental medical devices manufactured by YDM.
04963931102051 - NA2024-02-16 This device is a handle for attaching the working end of dental medical devices manufactured by YDM.

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