(277 days)
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No
The summary describes a standard ultrasonic dental scaling device and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is used to clean teeth via ultrasonic scaling, which is a therapeutic function. Also, the device is explicitly stated to be for "Prescription Use," which is typical for therapeutic devices.
No
The device is used for cleaning teeth by ultrasonic scaling, which is a therapeutic rather than a diagnostic function. It explicitly states its purpose is to "clean teeth."
No
The description explicitly states the device is an "ultrasonic scaling" device that is placed into a handpiece, indicating it is a physical component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "clean teeth by means of ultrasonic scaling." This is a physical procedure performed directly on the patient's teeth.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not involve testing samples from the body.
- Anatomical Site: The anatomical site is "teeth," which are part of the patient's body, not a sample taken from the body.
The description clearly indicates a device used for a therapeutic or procedural purpose directly on the patient, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
This product will be used by Dental professionals and authorized technicians to clean teeth by means of ultrasonic scaling. It can be placed into any approved 25K Ultrasonic Dental device handpiece on the market.
This devices is for Prescription Use as established by 21 CFR Part 801 Subpart D and it will be sold to the practitioner or through an authorized distributor.
Product codes
ELC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
teeth
Indicated Patient Age Range
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Intended User / Care Setting
Dental professionals and authorized technicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with a staff entwined by two snakes and topped with wings. The overall design is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2013
Mr. Joel Katz Engler Engineering Corporation 1099 East 47th Street HIALEAH FL 33013
Re: K122748
Trade/Device Name: 25K Series Insert Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: April 30, 2013 Received: May 29, 2013
Dear Mr. Katz:
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 (Act) that do not require approval 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.
1
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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Industrv/default.htm.
Sincerely vours.
Susan Runner DDS, MA Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
长122748
Engler Engineering Corporation 1099 East 47 Street Hialeah, FL 33013
Indication For Use
REF: 510(k) Number K122748/S001
`Device Name: 25K Series Insert
Indications for Use:
This product will be used by Dental professionals and authorized technicians to clean teeth by means of ultrasonic scaling. It can be placed into any approved 25K Ultrasonic Dental device handpiece on the market.
This devices is for Prescription Use as established by 21 CFR Part 801 Subpart D and it will be sold to the practitioner or through an authorized distributor.
Andrew I. Steen
2013.06.07 12:21:42 -04'00'
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
510(k) Number: K122748