(198 days)
No
The description details electronic control of motor functions and apex location based on distance, without mentioning AI/ML algorithms for analysis or decision-making.
Yes
The device is described as an "electronic digital control system indicated for endodontic treatment" and provides functions like "root canal length measurement" and "root canal treatment," which are therapeutic interventions.
Yes
The device is intended to measure the length of the dental root canal and locate the anatomical root canal apex, which are diagnostic measurements for endodontic treatment.
No
The device description explicitly lists multiple hardware components (central unit, micromotor, foot pedal, power supply, handpiece) and the performance studies include validation testing of both hardware and software functions.
Based on the provided information, the SiroEndo is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "dental root canal length measurement and root canal treatment." This is a direct clinical procedure performed on a patient's tooth, not a test performed on a sample taken from the body.
- Device Description: The description details an electronic system for controlling a micromotor and providing apex location information during a dental procedure. It does not describe any components or processes for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The SiroEndo is a medical device used during a dental procedure to assist the dentist in performing that procedure. It is not used to perform a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The SiroEndo is intended for dental root canal length measurement and root canal treatment.
Product codes
EKX
Device Description
The SiroEndo is an electronic digital control system indicated for endodontic treatment that allows a dentist to locate the anatomical root canal apex and to obtain root canal length measurements. The SiroEndo system is comprised of the central unit mounted via a support arm to a dental unit, micromotor, foot pedal and power supply. The central unit electronically controls the micromotor's rotation speed, rotation direction and torque. A commercially available handpiece is attached to the micromotor.
Systems of files are selectable with corresponding preset values for rotation speed and torque that are adjusted according to the entered handpiece reduction ratio. Individual values of rotation speed and torque can be entered and saved. File systems with individual values of rotation speed and torque can be stored in an internal memory or on a SiroEndo memory stick and can be re-called. The SiroEndo incorporates a selectable auto-stop and auto-reverse function triggered when the selected torque has been reached.
The SiroEndo offers a selectable apex locator feature that makes the distance between file tip and apex visible. The motor stops, if programmed, when the apex has been reached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist
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 to validate the safety and effectiveness of the SiroEndo 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)
Morita DENTAPORT ZX (K031204)
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
MAR 3 1 2006
.. -
510(k) Summary for Sirona Dental Systems SiroEndo
1. SPONSOR
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle 49 6251 16 32 94 Telephone:
Date Prepared: November 14, 2005
2. DEVICE NAME
| Proprietary Name: | SiroEndo |
|---|---|
| Common/Usual Name: | Dental root canal measurement and treatment device |
| Classification Names: | Dental Handpiece and Accessories and Root Apex |
| Locator |
3. PREDICATE DEVICE
Morita DENTAPORT ZX (K031204)
4. INTENDED USE
The SiroEndo is intended for dental root canal length measurement and root canal treatment.
1
ട. DEVICE DESCRIPTION
The SiroEndo is an electronic digital control system indicated for endodontic treatment that allows a dentist to locate the anatomical root canal apex and to obtain root canal length measurements. The SiroEndo system is comprised of the central unit mounted via a support arm to a dental unit, micromotor, foot pedal and power supply. The central unit electronically controls the micromotor's rotation speed, rotation direction and torque. A commercially available handpiece is attached to the micromotor.
Systems of files are selectable with corresponding preset values for rotation speed and torque that are adjusted according to the entered handpiece reduction ratio. Individual values of rotation speed and torque can be entered and saved. File systems with individual values of rotation speed and torque can be stored in an internal memory or on a SiroEndo memory stick and can be re-called. The SiroEndo incorporates a selectable auto-stop and auto-reverse function triggered when the selected torque has been reached.
The SiroEndo offers a selectable apex locator feature that makes the distance between file tip and apex visible. The motor stops, if programmed, when the apex has been reached.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The SiroEndo is substantially equivalent to the Morita DENTAPORT ZX (K031204) based on equivalence of the intended use, similar features and technical characteristics. Performance testing to validate the safety and effectiveness of the SiroEndo included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The seal is black and white and appears to be a simple, official emblem.
Public Health Service
MAR 3 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sirona Dental Systems GMBH C/O Ms. Mary McNamara-Cullinane Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760-4153
Re: K052515 Trade/Device Name: SiroEndo Regulation Number: 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: I Product Code: EKX Dated: March 16, 2006 Received: March 17, 2006
Dear Ms. McNamara-Cullinane:
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 (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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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); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Susan Panne
Chiu Lin, Ph.D 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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INDICATIONS FOR USE
510(k) Number (if known): 052515
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The SiroEndo is intended for dental root canal length measurement and root canal treatment.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sreen Kumar
1 2017 239, General H. 10 Denisle
November 14, 2005