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ProFile Vortex Obturator

FDA UDI

Class I (US FDA UDI)

by Tulsa Dental Products Llc

Identity

Trade Name
ProFile Vortex Obturator FDA UDI
Generic Name
Warm-bonded endodontic obturation system obturator FDA UDI
Device Name
Obt: Vortex Pl-Vent 6PK 50 FDA UDI
Model / Reference
VX05026 FDA UDI
Description
Obt: Vortex Pl-Vent 6PK 50 FDA UDI

Identifiers

Catalog Number
VX05026 FDA UDI
Primary DI / UDI-DI
D716VX050261 FDA UDI
FDA Product Code
EKM FDA UDI
GMDN Term
Warm-bonded endodontic obturation system obturator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

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: Warm-bonded endodontic obturation system obturator

ProFile Vortex Obturator by Tulsa Dental Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Warm-bonded endodontic obturation system obturator.

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 64d18330-aa08-4bc1-9911-3dfc314c0a3c 34 fields · synced Jun 8, 2026