Roydent Absortbent paper Points Zipperer

FDA UDI

Class I (US FDA UDI)

by Roydent Dental Products Inc

Identity

Trade Name: Roydent Absortbent paper Points Zipperer FDA UDI
Generic Name: Endodontic paper point FDA UDI
Device Name: Absorbent Points (standard/sterile) FDA UDI
Model / Reference: 0560035Z FDA UDI
Description: Absorbent Points (standard/sterile) FDA UDI

Identifiers

Catalog Number: 0560035Z FDA UDI
Primary DI / UDI-DI: D8090560035Z1 FDA UDI
FDA Product Code: EKN FDA UDI
GMDN Term: Endodontic paper point FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3830 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Endodontic paper point

Roydent Absortbent paper Points Zipperer by Roydent Dental Products Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic paper point.

EndoEssentials™ Absorbent Paper Points 200 - XC — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
Absorbant Paper Points, 45 — Meta Biomed, Inc. · Class I
ABSORBENT PAPER POINTS — DiaDent Group International · Class I
ABSORBENT PAPER POINTS — DiaDent Group International · Class I
Absorbant Paper Points, 10 — Meta Biomed, Inc. · Class I
MM MARKED PAPER POINTS — DiaDent Group International · Class I
MM MARKED PAPER POINTS — DiaDent Group International · Class I
MM MARKED PAPER POINTS — DiaDent Group International · 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

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

Manufacturer

Manufacturer: Roydent Dental Products Inc

Sources (1)

FDA UDI 68518736-3710-4b25-961f-af377f2b5980 34 fields · synced Jun 1, 2026