EASY X-TRAC SYSTEM

K060691 · A. Titan Instruments, Inc. · EMG · Jun 12, 2006 · Dental

Device Facts

• Record ID: K060691
• Device Name: EASY X-TRAC SYSTEM
• Applicant: A. Titan Instruments, Inc.
• Product Code: EMG · Dental
• Decision Date: Jun 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4565
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Easy X-Trac System is to be used to extract single and double rooted teeth as an implemented pre-implantological method by professionals only.

Device Story

The Easy X-Trac System is a manual surgical instrument used by dental professionals for tooth extraction. It functions by applying a vertical lifting motion to extract single or double-rooted teeth from the socket. Unlike traditional extraction forceps or elevators that may involve rotary or tilting movements, this system is designed to minimize bone loss and reduce damage to surrounding soft tissues, such as the lamella, buccal, and labial plates. By preserving the alveolus, the device facilitates immediate or delayed dental implant placement. The system is intended for use in a clinical setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual dental surgical instrument. Employs a vertical lifting mechanism to extract teeth without rotary or tilting forces. Designed to preserve alveolar bone and soft tissue plates. No electronic components, software, or energy sources.

Indications for Use

Indicated for the extraction of single and double rooted teeth, including broken-down, vertically fractured, or horizontally fractured teeth. For use by dental professionals only.

Regulatory Classification

Identification

A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.

Predicate Devices

• Meisinger Benex (510(k) exempt)

Submission Summary (Full Text)

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K06 0691

# 1. 510(k) Summarv

Submitter: A. Titan Instruments, Inc. JUN 1 2 2006

97 Main St. Address: Hamburg, NY 14075 USA

Phone number: [phone] Fax number: [phone] Contact person: Mr. Sebastian Czerny Date prepared: 05/23/06 Trade name: Easy X-Trac System Common name: Tooth Extraction System Classification name: Forceps, Tooth Extractor, Surgical Substantial equivalence claimed to:

1. Meisinger Benex, 872.4565 510(k) exempt

### Description:

The Easy X-Trac System is a tooth extraction system that is used to extract single- and double-rooted teeth. Use of this system may minimize bone loss, reduce damage to soft tissue and preserve the alveolous prior to immediate or delayed implant placement more than with regular extraction instruments such as extraction forceps and root elevators.

#### Intended use:

The Easy X-Trac System is to be used to extract single and double rooted teeth as an implemented pre-implantological method by professionals only.

# Summary of technological characteristics:

The Easy X-Trac System uses a complete vertical lifting motion without rotary- or tliting movements to lift a tooth out of the socket. By using this technique the user might have a greater chance of preserving the socket and preventing damage to hard soft tissues such as lamella and buccal and labial plates.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2006

Mr. Michael Tuber President A Titan Instruments, Incorporated 97 Main Street Hamburg, New York 14075

Re: K060691

Trade/Device Name: Easy X -Trac System Regulation Number: 872.4565 Regulation Name: Dental Hand Instrument Regulatory Class: I Product Code: EMG Dated: May 23, 2006 Received: May 24, 2006

Dear Mr. Tuber:

・

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 -Mr. Tuber

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sytte y. Michie Dond.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K060691

# 4. Indications for Use

510(k) Number: None currently exists.

Device Name: Easy X-Trac System

## Indications for Use:

The Easy X-Trac is only to be used for extraction of single and double rooted teeth by I he Lasy X-Trac is only. The system may be used to extract broken-down teeth with ucular professionals only . Its extract vertically or horizontally fractured teeth.

Prescription Use > (Per 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Ruase

11-6 11 of Anesthesiology, General Hospital, n Control, Dental Devices

Koloda