Top Quality Manufacturing

FDA UDI

Class I (US FDA UDI)

by Top Quality Manufacturing, Inc.

Identity

Trade Name: Top Quality Manufacturing FDA UDI
Generic Name: Endodontic paper point FDA UDI
Device Name: TQMPL Smart-Taper Absorbent Paper Points - F1 - 28 mm FDA UDI
Model / Reference: 12609241 FDA UDI
Description: TQMPL Smart-Taper Absorbent Paper Points - F1 - 28 mm FDA UDI

Identifiers

Primary DI / UDI-DI: TQ26126092411 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Endodontic paper point

Top Quality Manufacturing by Top Quality Manufacturing, 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
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: Top Quality Manufacturing, Inc.

Sources (1)

FDA UDI 54b9c73a-c4ff-414c-b73e-6e3f1abb3959 34 fields · synced May 31, 2026