(223 days)
Not Found
No
The description focuses on electrical impedance measurement and does not mention AI/ML terms or related concepts like training/test sets.
No
The device is used for locating the apex of the root canal, which is a diagnostic or measurement function and does not directly treat a disease or condition.
No
The device is described as an "APEX LOCATOR" which is intended for "locating the apex of the root canal" and to "estimate the position of the root apex of teeth during root canal preparation." While it provides information that aids in a procedure, its primary function is to provide positional estimation rather than to diagnose a medical condition or disease. It uses electrical impedance measurements to locate a anatomical landmark, not to assess health status or presence of pathology. Its purpose is to guide a treatment, not to diagnose a condition.
No
The device description explicitly lists hardware components (file clip, lip hook, external wiring) and describes its operation based on measuring electrical impedance, which requires hardware. Performance testing also includes electrical safety and electromagnetic compatibility, further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The APEX LOCATOR works by measuring electrical impedance within the root canal of a tooth in situ (inside the patient's mouth). It is used during a dental procedure on a living patient.
- Intended Use: The intended use is to locate the apex of the root canal during endodontic treatments, which is a procedural aid, not a diagnostic test performed on a specimen.
Therefore, the APEX LOCATOR falls under the category of a medical device used for a procedure on a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
APEX LOCATOR is a device intended for locating the apex of the root canal during endodontic treatments.
Product codes (comma separated list FDA assigned to the subject device)
LQY
Device Description
APEX LOCATOR is a device used in dentistry to estimate the position of the root apex of teeth during root canal preparation. It is used connected with the Cefla dental units. Its principle of operation relies on measuring the electrical impedance of dental tissue, which varies according to tissue density and composition.
The APEX LOCATOR is an accessory device for the Cefla dental units used to estimate the position of the root apex of teeth during root canal preparation. The kit is composed of the following elements: file clip (2 pieces), lip hook (4 piece), external wiring (1 piece).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal / Teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital environment, clinics or dental offices by qualified dental personnel
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)
Non-clinical Performance Testing:
Electrical safety Test was conducted and performed in accordance with IEC 60601-1.
Electromagnetic compatibility Test was conducted and performed in accordance with IEC 60601-1-2.
Usability test was conducted in accordance to IEC 60601-1-6.
Basic level software documentation per Content of Premarket Submissions for Device Software Functions.
Evaluation of biocompatibility is based on: ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and Testing";
Validation of the reprocessing according "FDA guidance Reprocessing Medical Devices Health Care Settings: Validation Methods and Labeling."
Performance tests have been performed according to internal protocol and method.
Clinical Testing:
Clinical performance testing was not conducted.
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
N/A
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
February 13, 2024
Cefla S.C. Daidone Simona Regulatory Affairs Via Selice Provinciale N.23/A Imola, Bologna 40026 ITALY
Re: K231990
Trade/Device Name: Apex Locator Regulatory Class: Unclassified Product Code: LQY Dated: January 17, 2024 Received: January 17, 2024
Dear Daidone Simona:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231990
Device Name APEX LOCATOR
Indications for Use (Describe)
APEX LOCATOR is a device intended for locating the apex of the root canal during endodontic treatments.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
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K231990
510(k) SUMMARY, AS REQUIRED BY CFR 807.92
| Submitter's Name: | CEFLA S.C. |
|---|---|
| Address: | Via Selice Provinciale 23/a |
| Imola, BO 40026 ITALY | |
| Tel. +39 0542 653111 | |
| Fax +39 0542 653444 | |
| Establishment | |
| Registration | |
| Number: | 3006610845 |
| Summary | |
| Preparation Date: | February, 12th, 2024 |
| Contact Person: | Simona Daidone, Regulatory Affairs |
| Telephone | |
| Number: | +39 0542 653441 |
| Email: | regulatory@cefla.it |
| Trade/Device | |
| name: | Apex Locator |
| Common or Usual | |
| Name: | Dental Root Apex Locator |
| Classification | |
| Name: | Classification Name: Unclassified |
| Device Class: Unclassified | |
| Product Code: LQY | |
| Description: | APEX LOCATOR is a device used in dentistry to estimate the position of the root apex of teeth during root canal preparation. It is used connected with |
| the Cefla dental units. Its principle of operation relies on measuring the electrical impedance of dental tissue, which varies according to tissue density | |
| and composition. | |
| The APEX LOCATOR is an accessory device for the Cefla dental units used to estimate the position of the root apex of teeth during root canal preparation. | |
| The kit is composed of the following elements: |
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CEFLA S.C. 510(k) Premarket Notification
| • | file clip (2 pieces) | ||
|---|---|---|---|
| • | lip hook (4 piece) | ||
| • | external wiring (1 piece) | ||
| Indication for Use: | APEX LOCATOR is a device intended for locating the apex of the root canal during endodontic treatments. | ||
| Identification of | |||
| Predicate Device: | CEFLA S.C. will refer to the following predicate device (1): | ||
| Proprietary Name: Guilin Woodpecker Medical Instrument | |||
| Classification Name: Unclassified | |||
| Registered Establishment Name: 3005581016 | |||
| Guilin Woodpecker Medical Instrument Co., Ltd. | |||
| Information Industrial Park, Guilin National High-Tech Zone | |||
| Guilin City, CN 541004Owner/Operator: W&H | |||
| Establishment Operations: Manufacturer | |||
| 510 (k): K181087 | |||
| Device Name: APEX LOCATOR DPEX III | |||
| Applicant: Guilin Woodpecker Medical Instrument | |||
| Comparison of | |||
| technological | |||
| characteristics | Characteristics | Subject Device | Predicate Device |
| Device Trade Name | Apex Locator | Apex Locator, DPEX III | |
| 510K Applicant | Cefla S.C. | GUILIN WOODPECKER MEDICAL |
| technological
characteristics
with the
predicate and
reference
| devices: | Device Trade Name | Apex Locator | Apex Locator, DPEX III | |
|---|---|---|---|---|
| 510K Applicant | Cefla S.C. | GUILIN WOODPECKER MEDICAL | ||
| INSTRUMENT CO., LTD | ||||
| 510(K) Number | - | K181087 | ||
| Regulation Number | Unclassified | Unclassified | ||
| Product Code | LQY | LQY | ||
| Classification Name | Root Apex Locator | Root Apex Locator | ||
| OTC or Prescription | Prescription Use | Prescription Use | ||
| Medical Specialty | Dental | Dental | ||
| Indications for Use | APEX LOCATOR is a device intended | |||
| for locating the apex of the root | ||||
| canal during endodontic treatments. | DPEX III is a microprocessor- | |||
| controlled device used for locating | ||||
| the apex of root canal. | ||||
| Electrical Power | Dental Unit power supply | Rechargeable lithium battery(3.7V) | ||
| Adapter | Not applicable | Input: AC100-240V 50/60Hz | ||
| Output: DC5V 1A | ||||
| Display | On the dental unit | Custom colorized 4.5" LCD | ||
| Measuring Voltage | Nominal – doesn't exceed 200mV | |||
| AC | Nominal - doesn't exceed 200mV | |||
| AC | ||||
| Frequencies used | ||||
| for measurements | 400Hz & 8kHz | 400Hz & 8kHz | ||
| Method of | ||||
| Calculation | The ratio of impedance at two | |||
| frequencies | The ratio of impedance at two | |||
| frequencies | ||||
| Accessory | Measuring wire, File clip, Lip hook, | |||
| Touch probe | Measuring wire, File clip, Lip hook, | |||
| Touch probe, Adapter, Tester | ||||
| Operating | ||||
| Environment | Hospital environment, clinics or | |||
| dental offices by qualified dental | ||||
| personnel | Hospital environment, clinics or | |||
| dental offices by qualified dental | ||||
| personnel | ||||
| Button | On the dental unit | Three push buttons: |
- ON/OFF
- Sound adjustment
- Demonstration function | |
| | Sound Indication | On the dental unit | Piezo transducer with sound level
control (high, medium, low, mute) | |
| | Automatic Turn off
function | Not present | The device turns off automatically
after 5 minutes of the idle state. | |
| | Calibration | Not required | Not required | |
| | Biocompatibility | Complies with ISO10993-1 | Complies with ISO10993-1 | |
| Non-clinical
Performance
Testing: | | Electrical safety Test was conducted and performed in accordance with IEC 60601-1. | | |
| | | Electromagnetic compatibility Test was conducted and performed in accordance with IEC 60601-1-2. | | |
| | | Usability test was conducted in accordance to IEC 60601-1-6. | | |
| | Basic level software documentation per Content of Premarket Submissions for Device Software Functions | | | |
| | | Evaluation of biocompatibility is based on: | | |
| | ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and Testing"; | | | |
| | Validation of the reprocessing according "FDA guidance Reprocessing Medical Devices Health Care Settings: Validation Methods and Labeling." | | | |
| | | Performance tests have been performed according to internal protocol and method. | | |
| Clinical Testing: | | Clinical performance testing was not conducted. | | |
| | | | | |
| Conclusion: | | CEFLA S.C. considers the Apex Locator to be substantially equivalent to the predicate device listed above. This conclusion is based on the similarities in | | |
| | | intended use, principle of operation, functional design, and established medical use. Differences between the devices shown in the comparison section | | |
| | | above are minor and do not have any negative effect on substantial equivalence. | | |
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