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Dental Engineering Lab-TFRK

FDA UDI

Class I (US FDA UDI)

by Dental Engineering Laboratories, LLC

Identity

Trade Name
Dental Engineering Lab-TFRK FDA UDI
Generic Name
Manual endodontic filling material spreader FDA UDI
Device Name
Gutta Percha Removal Instrument FDA UDI
Model / Reference
TFRK-GPR FDA UDI
Description
Gutta Percha Removal Instrument FDA UDI

Identifiers

Catalog Number
TFRK-GPR FDA UDI
Primary DI / UDI-DI
00850001745093 FDA UDI
FDA Product Code
DZN FDA UDI
GMDN Term
Manual endodontic filling material spreader FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 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

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Manual endodontic filling material spreader

Dental Engineering Lab-TFRK by Dental Engineering Laboratories, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual endodontic filling material spreader.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dental Engineering Laboratories, LLC

Sources (1)

  • FDA UDI 0c673d23-110d-4bad-be44-467d45c93268 35 fields · synced May 30, 2026