LUXATOR LX HANDPIECE

K133178 · Directa AB · EGS · Nov 24, 2015 · Dental

Device Facts

• Record ID: K133178
• Device Name: LUXATOR LX HANDPIECE
• Applicant: Directa AB
• Product Code: EGS · Dental
• Decision Date: Nov 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This device is designed to expand the tooth socket by widening the gap between root and bone to facilitate tooth removal due to caries, trauma, orthodontic reasons.

Device Story

Luxator® LX Handpiece is a dental instrument designed to facilitate tooth extraction. It functions by expanding the tooth socket, widening the gap between the tooth root and the surrounding bone. The device is used by dental professionals in a clinical setting to assist in the removal of teeth compromised by caries, trauma, or orthodontic requirements. By mechanically widening the periodontal space, the handpiece aids the clinician in the extraction process, potentially reducing trauma to the surrounding bone and simplifying the removal procedure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical dental handpiece. Designed for manual or powered socket expansion. Materials and construction consistent with standard dental surgical instruments. No electronic, software, or algorithmic components.

Indications for Use

Indicated for patients requiring tooth extraction due to caries, trauma, or orthodontic indications. Intended for use by dental professionals.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 24, 2015

Directa Ab Mr. Henric Karsk CEO P.O. Box 723 SE-194 47 Upplands Väsby SWEDEN

Re: K133178

Trade/Device Name: Luxator® LX Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpieces and accessories Regulatory Class: I Product Code: EGS Dated: October 13, 2015 Received: October 13, 2015

## Dear Mr. Karsk:

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 may, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Notification

LuxatorLX

## Indications for Use

510(k) Number (if known): K133178

Device Name: Luxator®LX handpiece

Indications for Use

This device is designed to expand the tooth socket by widening the gap between root and bone to facilitate tooth removal due to caries, trauma, orthodontic reasons.

> Prescription Use (Part 21 CFR 801 Subpart D

]Over-The-Counter Use (21 CFR 801 Subpart C

Concurrence of Center for Devices and Devices and Radiological Health (CDRG)