Lexicon

FDA UDI

Class I (US FDA UDI)

by Tulsa Dental Products Llc

Identity

Trade Name: Lexicon FDA UDI
Generic Name: Synthetic gutta-percha FDA UDI
Device Name: Gutta Percha: #90 ISO C120 FDA UDI
Model / Reference: GP90ISOC120 FDA UDI
Description: Gutta Percha: #90 ISO C120 FDA UDI

Identifiers

Catalog Number: GP90ISOC120 FDA UDI
Primary DI / UDI-DI: D716GP90ISOC1201 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Liquid Chemical FDA UDI

Category: Synthetic gutta-percha

Lexicon 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
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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 2a2d189c-26e8-49e0-9593-27f4819b959e 34 fields · synced May 31, 2026