Vortex Gutta Percha Points

FDA UDI

Class I (US FDA UDI)

by Tulsa Dental Products Llc

Identity

Trade Name: Vortex Gutta Percha Points FDA UDI
Generic Name: Synthetic gutta-percha FDA UDI
Device Name: Vortex Gp Points 04/25 FDA UDI
Model / Reference: VXGP0425 FDA UDI
Description: Vortex Gp Points 04/25 FDA UDI

Identifiers

Catalog Number: VXGP0425 FDA UDI
Primary DI / UDI-DI: D716VXGP04251 FDA UDI
FDA Product Code: EKM FDA UDI
GMDN Term: Synthetic gutta-percha 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Liquid Chemical FDA UDI

Category: Synthetic gutta-percha

Vortex Gutta Percha Points by Tulsa Dental Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Synthetic gutta-percha.

Gutta Percha Points — ROYDENT DENTAL PRODUCTS INC · Class I
Roydent Gutta Percha — ROYDENT DENTAL PRODUCTS INC · Class I
MX 06-20 — Meta Biomed, Inc. · Class I
Safco gutta percha points — Safco Dental Supply · Class I
EdgeSequel™ — US Endodontics, LLC · Class I
Gutta Percha 02-80 — Meta Biomed, Inc. · Class I
Gutta Percha 04-45 — Meta Biomed, Inc. · Class I
Henry Schein — HENRY SCHEIN, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Tulsa Dental Products Llc

Sources (1)

FDA UDI 78f3e7cd-950f-4eff-9e44-494177328fcb 34 fields · synced Jun 8, 2026