3D Endo

FDA UDI

Class I (US FDA UDI)

by 3d Dental Designs And Development, Llc

Identity

Trade Name: 3D Endo FDA UDI
Generic Name: Endodontic paper point FDA UDI
Device Name: Absorbant Paper Points Box/60 Tapered .04 #45-80 FDA UDI
Model / Reference: 3D-PPB4580T4 FDA UDI
Description: Absorbant Paper Points Box/60 Tapered .04 #45-80 FDA UDI

Identifiers

Catalog Number: 3D-PPB4580T4 FDA UDI
Primary DI / UDI-DI: 00810126503466 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Endodontic paper point

3D Endo by 3d Dental Designs And Development, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Endodontic paper point.

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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
Roydent Absortbent paper Points Zipperer — ROYDENT DENTAL PRODUCTS INC · 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

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Manufacturer

Manufacturer: 3d Dental Designs And Development, Llc

Sources (1)

FDA UDI 6c96e70f-edc1-4dac-9cfe-af68fde1b6b8 34 fields · synced May 31, 2026