(98 days)
No
The summary describes a standard electric motor-driven handpiece for endodontic procedures and does not mention any AI or ML capabilities.
No
The device is used for preparing the root canal (a procedure), not for treating a specific disease or condition. While part of a therapeutic process, the device itself is a tool for preparation rather than therapy.
No
The device description states it is "an electric motor-driven handpiece intended for root canal preparation procedures," which describes a treatment or intervention device, not one used for diagnosis.
No
The device description explicitly states it is an "electric motor-driven handpiece," which is a hardware component. The performance studies also mention validation of both hardware and software functions.
Based on the provided information, the X-Smart Easy is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden)" and "root canal preparation procedures." This describes a procedure performed on a patient's body (in vivo), not on a sample taken from a patient's body (in vitro).
- Device Description: It's described as an "electric motor-driven handpiece intended for root canal preparation procedures." This is a tool used directly in a dental procedure.
- Anatomical Site: The anatomical site is the "Root canal," which is part of the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), reagents, or diagnostic information derived from samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The X-Smart Easy is a therapeutic/procedural device used directly on the patient.
N/A
Intended Use / Indications for Use
X-Smart Easy is designed for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).
Product codes
EKX
Device Description
The X-Smart Easy is an electric motor-driven handpiece intended for root canal preparation procedures in endodontic industry.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
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)
Performance testing was performed to validate the safety and effectiveness of the X-Smart Easy, which included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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K092614
DENTSPLY International
World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 (717) 845-7511 {voice} (717) 849-4343 (fax) www.dentsply.com
DEC - 2 2009
510(k) Summary for X-Smart Easy
-
- Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |
Date Prepared:
18 August 2009
-
Device Name: 2.
Proprietary Name: X-Smart Easy Classification Name: Dental Handpiece and Accessories 872.4200 CFR Number: Device Class: I EKX Product Code: -
- Predicate Device: Prophy-Mate and Endo Mate Motor Handpiece (K990682)
-
Description of Device: 4. The X-Smart Easy is an electric motor-driven handpiece intended for root canal preparation procedures in endodontic industry.
-
న్. Indications for Use:
X-Smart Easy is designed for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).
- Description of Safety and Substantial Equivalence 6.
Technological Characteristics
Patient contact elements of the components found in X-Smart Easy have been used in legally marketed devices and/or were found safe for dental use.
DENTSPLY International | X-Smart Easy 18 August 2009
9
- ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
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1
Non-Clinical Performance
Biocompatibility Testing
Cytotoxicity, sensitization and irritation testing were performed in accordance with ISO 10993. All patient contact components demonstrated biocompatibility.
Electromagnetic Compatibility and Electrical Safetv
The X-Smart East conforms to UL60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety; IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility; and IEC 61000-3-2 Electromagnetic Compatibility (EMC) Part 3: Limits - Section 3: Limitations of Voltage Fluctuations.
Conclusion as to Substantial Equivalence
The X-Smart Easy is substantially equivalent to the Prophy Mate and Endo Mate Handpiece (K990682) based on equivalence of the intended use, similar features and technical characteristics. Performance testing was performed to validate the safety and effectiveness of the X-Smart Easy, which included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions. The X-Smart Easy does not raise any new issues of safety, effectiveness, or performance of the product.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a family of three figures, with the central figure slightly taller than the others.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Helen Lewis Director DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
DEC - 2 2009
Re: K092614 Trade/Device Name: X-Smart Easy Regulation Number: 21CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: November 24, 2009 Received: November 25, 2009
Dear Ms. Lewis:
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- Ms. Lewis
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,
for
Susan Runner, D.D.S., M.A. Acting Division Director . Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
1092614 510(k) Number (if known):
Device Name: X-Smart Easy
Indications for Use:
X-Smart Easy is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).
Prescription Use X (Part 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)
Kain Hurley for NSR
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division of Andelhoental Devices
510(k) Number: