ProUltra PiezoFlow PIEZOFLOWREFILL

GUDID D716PIEZOFLOWREFILL0

PiezoFlow Refill Pack

TULSA DENTAL PRODUCTS LLC

Root canal ultrasonic irrigation handpiece tip
Primary Device IDD716PIEZOFLOWREFILL0
NIH Device Record Keye18ca0f3-3e3b-4f2c-9e08-992348919e62
Commercial Distribution StatusIn Commercial Distribution
Brand NameProUltra PiezoFlow
Version Model NumberPIEZOFLOWREFILL
Catalog NumberPIEZOFLOWREFILL
Company DUNS942778564
Company NameTULSA DENTAL PRODUCTS LLC
Device Count24
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD716PIEZOFLOWREFILL0 [Unit of Use]
HIBCCD716PIEZOFLOWREFILL1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D716PIEZOFLOWREFILL0]

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[D716PIEZOFLOWREFILL0]

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[D716PIEZOFLOWREFILL0]

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[D716PIEZOFLOWREFILL0]

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[D716PIEZOFLOWREFILL0]

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[D716PIEZOFLOWREFILL0]

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[D716PIEZOFLOWREFILL0]

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[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


[D716PIEZOFLOWREFILL0]

Liquid Chemical


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-26
Device Publish Date2022-10-18

On-Brand Devices [ProUltra PiezoFlow]

D716PIEZOFLOWSOLO1ProUltra PiezoFlow SOLO
D716PIEZOFLOWREFILL0PiezoFlow Refill Pack
D716PIEZOFLOWAP1ProUltra PiezoFlow Acc Pack

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