(65 days)
Not Found
Not Found
No
The provided text describes a standard ultrasonic scaler for dental procedures and contains no mention of AI, ML, or related concepts.
Yes
The device is described as an "ultrasonic scaler" designed for "prophylaxis treatments, periodontia, and other areas of operative dentistry," which are all therapeutic dental procedures.
No
The device description states it is "DESIGNED FOR USE IN PROPHYLAXIS TREATMENTS PERIODONTIA , AND OTHER AREAS OF OPERATIVE DENTISTRY," which are treatment-oriented uses, not diagnostic.
No
The device description is not found, but the intended use clearly describes an "ULTRASONIC SCALER," which is a hardware device used in dentistry. This indicates it is not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an "ULTRASONIC SCALER" used for "PROPHYLAXIS TREATMENTS PERIODONTIA , AND OTHER AREAS OF OPERATIVE DENTISTRY." These are procedures performed directly on a patient's teeth and gums.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro analysis.
- Use in a laboratory setting.
An ultrasonic scaler is a medical device used for cleaning teeth, which is a direct treatment on the patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
THE ELEGANCE MS-10 (25K) ULTRASONIC SCALER IS DESIGNED FOR USE IN PROPHYLAXIS TREATMENTS PERIODONTIA , AND OTHER AREAS OF OPERATIVE DENTISTRY.
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
Not Found
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle, with three stylized lines representing its wings. The eagle is facing to the right.
Public Health Service
APR 2 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sterling Cheng Manager Rolence Enterprise Incorporated 18-3, Lane 231, Pu Chung Road Chungli 320, Taiwan R.O.C.
Re: K040396
Trade/Device Name: Elegance MS-10 (25k) Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 6, 2004 Received: February 17, 2004
Dear Mr. Cheng:
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 approvisions 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 such additional controls. Existing major regulations affecting (1 WI (), it may be outsyst to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Cheng
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 moan that I Dr mas made a aves and regulations administered by other Federal agencies. of the Act of ally I oderal bates as requirements, including, but not limited to: registration 1 ou must comply with an are reseling (21 CFR Part 801); good manufacturing practice and listing (21 CF reful 007), accling systems (QS) regulation (21 CFR Part 820); and if requirements us bet form in are quadis ion control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This reter will and in J . The FDA finding of substantial equivalence of your device to a premarket nonneation - The PDF 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), 11 you desire specific af Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Qiu Lin, Ph.D.
nu 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
2
Indications for Use
. .
510(k) Number (if known):___K040396
Device Name: ELEGANCE MS-10 (25k) ULTRASONIC SCALER
Indications for Use:
THE ELEGANCE MS-10 (25K) ULTRASONIC SCALER IS DESIGNED FOR USE IN PROPHYLAXIS TREATMENTS PERIODONTIA , AND OTHER AREAS OF OPERATIVE DENTISTRY.
AND/OR Prescription Use x _ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Arbutz Beitz MD for Dr. Susan Kummer
(Division Sign-(Division Sign-Off, General Hospital, Infection Control, Dental Devices
510(k) Number. K040396