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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 25 .06 Taper FDA UDI
Model / Reference
1637 FDA UDI
Description
EndoRez Points 25 .06 Taper FDA UDI

Identifiers

Catalog Number
1637 FDA UDI
Primary DI / UDI-DI
00883205021267 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

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Manufacturer

Manufacturer
Ultradent Products, Inc.

Sources (1)

  • FDA UDI c9e563d3-9cec-44ca-99bb-7df5928106c7 35 fields · synced May 31, 2026