X-CUBE

K092758 · Saeshin Precision Co., Ltd. · EBW · Sep 21, 2009 · Dental

Device Facts

• Record ID: K092758
• Device Name: X-CUBE
• Applicant: Saeshin Precision Co., Ltd.
• Product Code: EBW · Dental
• Decision Date: Sep 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The X-CUBE is intended for use in dental surgery, implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.

Device Story

X-CUBE is an AC-powered surgical motor unit for dental implantology and maxilla-facial surgery. System components include a hand-held motor, controller, and foot controller. Device facilitates speed and rotation control for dental handpieces or contra-angle attachments. Used in clinical dental settings by dental professionals. Provides mechanical power for rotating instruments to treat hard tissue or perform root canal preparation. Output allows clinicians to perform precise surgical procedures; benefits include controlled mechanical assistance for dental interventions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparison to the predicate device.

Technological Characteristics

AC-powered surgical motor unit. Includes hand-held motor, controller, and foot controller. Designed for dental handpiece/contra-angle attachment integration. Regulates speed and direction of rotation. Class I device (21 CFR 872.4200).

Indications for Use

Indicated for dental surgery, implantology, maxilla-facial surgery, and endodontics, specifically for the treatment of dental hard tissue and mechanical rotating root canal preparation.

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.

Predicate Devices

• ImplantMED SI-915/923 (K052741)

Submission Summary (Full Text)

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K092758

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

Date: January 21, 2009

1. Company and Correspondent making the submission:

| | Company |
|-------------------------|---------------------------------------------------------------------|
| Name | Saeshin Precision Co., Ltd. |
| Address | #93-15, Paho-dong, Dalseo-Gu, Daegu, 704-<br>220, Republic of Korea |
| Phone<br>Fax<br>Contact | [phone]<br>[phone]<br>Y. S. Lee |

2. Device:

Proprietary Name - X-CUBE

Common Name - Surgical motor unit for implantology and maxilla surgery Classification Name - Controller, Foot, Handpiece and Cord

- 3. Predicate Device:
ImplantMED SI-915/923, K052741

- 4. Classifications Names & Citations: EBW, 872,4200
- 5. Description:

The X-CUBE, Implant Engine, is an AC-powered device that includes a hand-held motor, controller and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental implant surgery.

- 6. Indication for use:
The X-CUBE is intended for use in dental surgery, implentology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.

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# AEGHIN

# Saeshin Precision Ind. Co.

#93-15, Paho-Dong, Dalseo-Gu, Daegu, 704-220, Republic of Korea Tel [phone] Fax [phone]

- 7. Review:
The X-CUBE has the same device characteristics as the predicate device, the ImplantMED SI-915/923; intended use, material, design and use concept are similar.

Based on the comparison of intended use and technical features, the X-CUBE is substantially equivalent to the predicate device.

- 8. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Saeshin Precision Co., Ltd. concludes that the X-CUBE are safe and effective and substantially equivalent to predicate devices as described herein.

- 9. Saeshin Precision Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
END

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

SEP 2 1 2009

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

Saeshin Precision Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-9526

Re: K092758

Trade/Device Name: X-CUBE Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: August 20, 2009 Received: September 9, 2009

#### Dear Mr. Mouser:

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.

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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### Page 2- Mr. Mouser

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 device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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Susan Runner, D.D.S., M.A. Acting 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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510(k) Submissian - X-CUBE ... ... ... ... ...

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Device Name: X-CUBE

Indication for use:

The X-CUBE is intended for use in dental surgery, implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.

Prescription Use (Per 21 CFR801 Subpart D)

Over-The-Counter Use (Per 21CFR807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Maby

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

ાર

510(k) Number: K092758

SAESHIN PRECISION CO., LTD.

00-MB-F0031 - Rev. 2.2