A. Titan Instruments

FDA UDI

Class I (US FDA UDI)

by A.Titan Instruments

Identity

Trade Name: A. Titan Instruments FDA UDI
Generic Name: Tooth extraction forceps FDA UDI
Device Name: Essential X Trac Kit FDA UDI
Model / Reference: K-4200 FDA UDI
Description: Essential X Trac Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 00841685111465 FDA UDI
510(k) Number: K060691 FDA UDI
FDA Product Code: EMG FDA UDI
GMDN Term: Tooth extraction forceps FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Dry Heat Sterilization FDA UDI

Category: Tooth extraction forceps

A. Titan Instruments by A.Titan Instruments — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tooth extraction forceps.

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devemed — devemed GmbH · Class I
Power Dental USA — Power Dental USA, Inc. · Class I
CROWN SPLITTER ON LARGE T BAR — W.H. Holden, Inc. · Class I
NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
ZOLL-DENTAL — Zoll-Dental · Class I

Cleared under the same submission

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: A.Titan Instruments

Sources (1)

FDA UDI dde0a252-f976-456a-9b80-eb68fd2d4d38 34 fields · synced Jun 9, 2026