TPC a750led

GUDID D861A750LED0

scaler with led to remove calculus

TPC ADVANCE TECHNOLOGY, INC.

Rotary dental scaler
Primary Device IDD861A750LED0
NIH Device Record Key45966800-9b15-43c7-a692-bc0e54cb0007
Commercial Distribution StatusIn Commercial Distribution
Brand NameTPC
Version Model Numbera750led
Catalog Numbera750led
Company DUNS968884275
Company NameTPC ADVANCE TECHNOLOGY, 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 Batchtrue
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
HIBCCD861A750LED0 [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 Date2017-09-11

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