ProUltra Piezo PULTRAPZ

GUDID D716PULTRAPZ1

ProUltra Piezo Ultrasonic

TULSA DENTAL PRODUCTS LLC

Ultrasonic dental scaling/debridement system
Primary Device IDD716PULTRAPZ1
NIH Device Record Keye9af6f6d-fa87-42c6-a23a-edd8fb37b6f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameProUltra Piezo
Version Model NumberPULTRAPZ
Catalog NumberPULTRAPZ
Company DUNS942778564
Company NameTULSA DENTAL PRODUCTS LLC
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 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
HIBCCD716PULTRAPZ1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[D716PULTRAPZ1]

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Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-25
Device Publish Date2022-10-17

On-Brand Devices [ProUltra Piezo]

D716PULTRAPZHP1ProUltra Piezo Handpiece
D716PULTRAPZ1ProUltra Piezo Ultrasonic

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