(65 days)
THE ELEGANCE MS-10 (25K) ULTRASONIC SCALER IS DESIGNED FOR USE IN PROPHYLAXIS TREATMENTS PERIODONTIA , AND OTHER AREAS OF OPERATIVE DENTISTRY.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the Elegance MS-10 (25k) Ultrasonic Scaler. It does not contain information about acceptance criteria, specific study designs, or performance data for a device meeting acceptance criteria.
The letter explicitly states: "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..."
This means the device was cleared based on its substantial equivalence to a predicate device, not necessarily on a study demonstrating it met specific acceptance criteria. A 510(k) submission typically includes a comparison to a legally marketed predicate device, addressing aspects like technological characteristics and performance, but it often does not involve the kind of detailed clinical study with acceptance criteria, ground truth, and expert evaluation described in your request for AI/medical imaging devices.
Therefore, I cannot provide the requested information from this document. The document confirms the device's clearance for marketing and its intended use, but it does not detail the specific performance metrics or studies you are asking for.
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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.
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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
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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
§ 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.