← Back to catalogue

EndoREZ Points

FDA UDI

Class I (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name
EndoREZ Points FDA UDI
Generic Name
Natural gutta-percha FDA UDI
Device Name
EndoRez Points 20 .04 Taper FDA UDI
Model / Reference
1839 FDA UDI
Description
EndoRez Points 20 .04 Taper FDA UDI

Identifiers

Catalog Number
1839 FDA UDI
Primary DI / UDI-DI
00883205020857 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

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Natural gutta-percha

EndoREZ Points by Ultradent Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Natural gutta-percha.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ultradent Products, Inc.

Sources (1)

  • FDA UDI d567ccca-4974-4507-83bd-5f81f1948d2b 35 fields · synced May 31, 2026