(70 days)
No
The summary describes a standard endodontic motor and controller, with no mention of AI, ML, image processing, or data-driven performance metrics.
No.
The device is used in standard endodontic procedures but does not explicitly state that it treats or prevents a disease or condition, which is a key characteristic of a therapeutic device. Its predicate devices also suggest it's more of a surgical/procedural tool rather than a therapeutic one.
No
The device description indicates it is used for procedures using rotary endodontic files and drills, or for dental implant surgery. It controls speed and direction of rotation, which are treatment functions, not diagnostic ones.
No
The device description explicitly states it is an "AC-powered device that includes a hand-held motor and controller," indicating it is a hardware device, not software-only.
Based on the provided information, the E-CUBE is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for standard endodontic procedures using rotary files and drills, and for dental implant surgery. These are procedures performed directly on the patient's body, not on samples taken from the body.
- Device Description: The device is a motor and controller for regulating the speed and direction of rotation of dental tools. This is a mechanical device used for physical manipulation during a procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body. The E-CUBE's function is entirely in vivo (within the living body) during dental procedures.
N/A
Intended Use / Indications for Use
The E-CUBE is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills(Gates-Glidden).
Product codes
EKX
Device Description
The E-CUBE is an AC-powered device that includes a hand-held motor and 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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)
X-Smart Easy, K092614, STRONG Implant Handpiece, K092412
Reference Device(s)
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
Image /page/0/Picture/2 description: The image shows the logo for Saeshin. The logo consists of a stylized letter "S" on the left and the word "SAESHIN" on the right. The letter "S" is formed by a white shape inside a black circle. The word "SAESHIN" is written in a bold, sans-serif font.
AUG 1 9 2011 Saeshin Precision Co., Ltd.
#93-15, Paho-Dong, Dalseo-Gu, Daegu, 704-220, Republic of Korea Tel 82 53-587-2345 Fax 82 53-587-2347
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).
October 11, 2010 Date:
- 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 |
2. Device:
Proprietary Name - E-CUBE Common Name -- Dental handpiece and accessories Classification Name - Handpiece, Direct drive, AC-powered
3. Predicate Device:
X-Smart Easy, K092614 STRONG Implant Handpiece, K092412
-
- Classifications Names & Citations: EKX. 872.4200
-
- Description:
The E-CUBE is an AC-powered device that includes a hand-held motor and controller for regulation of speed and direction of rotation or a contra-angle attachment for dental implant surgery.
6. Indication for use:
The E-CUBE is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills(Gates-Glidden).
-
- Review:
The E-CUBE has the same device characteristics as the predicate device, the X-Smart Easy; intended use, material, design and use concept are similar.
- Review:
1
Image /page/1/Picture/1 description: The image shows the logo for SAESHIN. The logo consists of a stylized circle with a white shape inside, resembling a crescent or a curved blade. To the right of the circle is the company name, "SAESHIN," in bold, sans-serif font.
Saeshin Precision Co., Ltd.
#93-15, Paho-Dong, Dalseo-Gu, Daegu, 704-220, Republic of Korea Tel 82 53-587-2345 Fax 82 53-587-2347
The biocompatibility of the patient contact parts has been demonstrated through the cytotoxicity, sensitization and irritation testing by ISO 10993-1 Biological evaluation of medical devices - Part1 Evaluation and Testing. The contacting materials of the E-CUBE are the same as those of the STRONG Implant Handpieces (K09212),
The E-CUBE conforms to IEC 60601-1 Medical electric equipment, Part 1: General requirements for safety and IEC 60601-1-2 Medical electric equipment, General requirements for safety collateral standard electromagnetic compatibility.
Based on the comparison of intended use and technical features, the E-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 E-CUBE are safe and effective and substantially equivalent to predicate devices as described herein.
-
- 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
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the circle is a stylized image of a bird or other winged creature. The image is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -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 North West Lake Road Camas, Washington 98607
AUG 1 9 2011
Re: K111616
Trade/Device Name: E-Cube Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Headpiece and Accessories Regulatory Class: I Product Code: EKX Dated: August 12, 2011 Received: August 15, 2011
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. 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.
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 /uc.m115809.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.
Anthony V. winter
Anthony B. Watson, B.S., M.S., M.B.A. 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) Submission - E-CUBE
510(k) Number K
Device Name: E-CUBE
Indication for use:
The E-CUBE is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills(Gates-Glidden).
Prescription Use (Per 21CFR801 Subpart D)
OR 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)
Susan Runse
(Division Sign-Off)
Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K11616