Vortex Blue Conform Fit

FDA UDI

Class I (US FDA UDI)

by Tulsa Dental Products Llc

Identity

Trade Name: Vortex Blue Conform Fit FDA UDI
Generic Name: Synthetic gutta-percha FDA UDI
Device Name: Conform Fit Vortex Blue GPMC0630 60 QTY FDA UDI
Model / Reference: VTBGP0630 FDA UDI
Description: Conform Fit Vortex Blue GPMC0630 60 QTY FDA UDI

Identifiers

Catalog Number: VTBGP0630 FDA UDI
Primary DI / UDI-DI: D716VTBGP06301 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Synthetic gutta-percha

Vortex Blue Conform Fit by Tulsa Dental Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 9cf0cc34-d194-44e5-806d-5fbe95de1545 36 fields · synced May 30, 2026