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ProUltra PiezoFlow

FDA UDI

Class II (US FDA UDI)

by Tulsa Dental Products Llc

Identity

Trade Name
ProUltra PiezoFlow FDA UDI
Generic Name
Root canal ultrasonic irrigation handpiece tip FDA UDI
Device Name
ProUltra PiezoFlow Acc Pack FDA UDI
Model / Reference
PIEZOFLOWAP FDA UDI
Description
ProUltra PiezoFlow Acc Pack FDA UDI

Identifiers

Catalog Number
PIEZOFLOWAP FDA UDI
Primary DI / UDI-DI
D716PIEZOFLOWAP1 FDA UDI
FDA Product Code
ELC FDA UDI
GMDN Term
Root canal ultrasonic irrigation handpiece tip FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Liquid Chemical FDA UDI

Category: Root canal ultrasonic irrigation handpiece tip

ProUltra PiezoFlow by Tulsa Dental Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Root canal ultrasonic irrigation handpiece tip.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tulsa Dental Products Llc

Sources (1)

  • FDA UDI 919beb5a-c164-44cc-9158-5c81f62765cf 34 fields · synced May 30, 2026