(86 days)
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Not Found
No
The summary describes a mechanical dental scaler and makes no mention of AI or ML.
No
The device is described as an "air scaler" for removing calculus and stains, which is typically a dental hygiene procedure rather than a therapeutic treatment for disease or injury.
No
This device is described as an "air scaler" intended to "remove calculus deposits and stains from a tooth." This is a therapeutic or prophylactic function, not a diagnostic one (identifying a disease or condition).
No
The device description explicitly states it is an "air-powered, fiber optic, swivel air scaler," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove calculus deposits and stains from a tooth. This is a physical procedure performed directly on the patient's tooth.
- Device Description: The device is an air-powered, fiber optic, swivel air scaler. This describes a tool used for mechanical removal.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to perform procedures on the body itself. This device is a dental instrument used for a physical cleaning procedure.
N/A
Intended Use / Indications for Use
This device, an air-powered, fiber optic, swivel air scaler, is intended for use to remove calculus deposits and stains from a tooth, as done in normal dental scaling operation . The device uses controlled water spray and an appropriate scaling tip to wash away removed calculus and stains.
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
tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
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.)
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.
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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.
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
§ 872.4850 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.
0
Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 23 1999
Mr. Hiroji Sekiguchi Marketing Manager-North America Official Correspondent Nakanishi, Incorporated 340 Kamihinata, Kanuma-Shi, Tochiqi-Ken 322 JAPAN
Re : K991021 Sonic Scaler with Fiber Optic, Model NAS-L, Trade Name: Sonic Scaler with Fiber Optic, Model NAS-NL Regulatory Class: II Product Code: ELC March 26, 1999 Dated: March 29, 1999 Received:
Dear Mr. Sekiguchi:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 — Mr. Sekiguchi
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acboirson in four in four alence 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directdr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): 1991021
Devicc Namc:
Indications For Usc:
This device, an air-powered, fiber optic, swivel air scaler, is intended for use to remove calculus deposits and stains from a tooth, as done in normal dental scaling operation . The device uses controlled water spray and an appropriate scaling tip to wash away removed calculus and stains.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Coucurcuce of CDRH, Office of Device Evaluation (ODE)
| Susan Runne (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | ||
|---|---|---|
| 510(k) Number | K991021 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Formal I -