Gutta Percha Points

FDA UDI

Class I (US FDA UDI)

by DiaDent Group International

Identity

Trade Name: GUTTA PERCHA POINTS FDA UDI
Generic Name: Natural gutta-percha FDA UDI
Device Name: Gutta Percha Points is used to root canal filing material. FDA UDI
Model / Reference: DIA-PRO-.06 4 FDA UDI
Description: Gutta Percha Points is used to root canal filing material. FDA UDI

Identifiers

Catalog Number: 110-604 FDA UDI
Primary DI / UDI-DI: 08806383504010 FDA UDI
FDA Product Code: EKM FDA UDI
GMDN Term: Natural 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

Yes

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

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Natural gutta-percha

Gutta Percha Points is a dental material used for root canal filing. This device is made from coagulated sap of certain tropical trees, intended to fill the root canal of a tooth and harden as it cools. It has been cleared by regulatory authorities for medical use in the US and is exempt from post-market surveillance. The device was manufactured before 2020-04-06 but has not yet reached its expiration date.

Similar devices

Also classified as Natural gutta-percha.

SSW ENDO — SS White Burs LLC · Class I
DCTAPER — SS White Burs LLC · Class I
Top Quality Manufacturing — TOP QUALITY MANUFACTURING, INC. · Class I
GuttaCore Obturator — TULSA DENTAL PRODUCTS LLC · Class I
Patterson — PATTERSON DENTAL SUPPLY, INC. · Class I
DCTAPER — SS White Burs LLC · Class I
EndoREZ Points — ULTRADENT PRODUCTS, 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: DiaDent Group International

Sources (1)

FDA UDI 548bb97a-87bb-4c00-8368-23066209870f 35 fields · synced Oct 6, 2026