(12 days)
Not Found
No
The summary describes a mechanical device for dental procedures with no mention of AI or ML capabilities.
Yes
The device is intended for "treatment of dental hard tissue and mechanical rotating root canal preparation," which directly indicates a therapeutic purpose.
No
The device is described as an "Implant Engine" intended for "treatment of dental hard tissue and mechanical rotating root canal preparation," which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states it is an AC-powered device that includes hardware components such as a hand-held motor, controller, and foot controller.
Based on the provided information, the X-CUBE is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "treatment of dental hard tissue and mechanical rotating root canal preparation." This describes a therapeutic or surgical procedure performed directly on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description details a device used for mechanical manipulation (motor, controller, foot controller, contra-angle attachment). This aligns with a surgical or treatment device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing diagnostic tests, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The X-CUBE's function falls outside this definition.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental hard tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental surgery, implentology, maxilla-facial surgery and endodontics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
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.(b)
Classification. Class I.
0
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
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | Saeshin Precision Co., Ltd. |
| Address | #93-15, Paho-dong, Dalseo-Gu, Daegu, 704- |
| 220, Republic of Korea | |
| Phone | |
| Fax | |
| Contact | +82 53-587-2345 |
| +82 53-587-2347 | |
| Y. S. Lee |
- Device:
Proprietary Name - X-CUBE
Common Name - Surgical motor unit for implantology and maxilla surgery Classification Name - Controller, Foot, Handpiece and Cord
-
- Predicate Device:
ImplantMED SI-915/923, K052741
- Predicate Device:
-
- Classifications Names & Citations: EBW, 872,4200
-
- 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.
-
- 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.
- Indication for use:
1
AEGHIN
Saeshin Precision Ind. Co.
#93-15, Paho-Dong, Dalseo-Gu, Daegu, 704-220, Republic of Korea Tel 82 53-587-2345 Fax 82 53-587-2347
-
- 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.
- Review:
Based on the comparison of intended use and technical features, the X-CUBE is substantially equivalent to the predicate device.
-
- 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.
- Conclusions:
-
- Saeshin Precision Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
END
- Saeshin Precision Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
2
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.
3
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ph foo
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
4
510(k) Submissian - X-CUBE ... ... ... ... ...
ુત્વ દિવેલા કુલ ૧૯૮૮ – ૧૮૮૮ – ૧૮૮૮ – ૧૮૮૮ – ૧૮૮૮ – ૧૮૮૮ – ૧૮૮૮ – ૧૮૮૮ – ૧૮૮ – ૧૮૮ – ૧૮૮ – ૧૮૮ – ૧૮૮ – ૧૮૮ – ૧૮૮ – ૧૮૮ – ૧૮૮ – ૧૮ – ૧૮ – ૧૮ – ૧૮ – ૧૮ – ૧૮ – ૧૮ – ૧૮ – ૧ – ૧ – 510(k) Number K
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