(449 days)
The Dream Cleans "S" Scaler and Dream Compact "S" scalers are hand held ultrasonic instruments used for removal of supragingival and subgingival calculus and stains from teeth. They are also used for periodontal scaling and root planing.
hand held ultrasonic instruments
The provided document is an FDA 510(k) clearance letter for the "Dream Cleans 'S' Scaler and Compact 'S' Scaler." This type of document does not contain information about acceptance criteria or detailed study results for device performance.
The 510(k) clearance process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove safety and effectiveness from scratch. It relies on a comparison of technological characteristics and indications for use.
Therefore, I cannot extract the requested information from this document. To answer your questions, one would typically need access to the 510(k) submission itself or a separate study report.
Here's why the document doesn't contain the requested information:
- Acceptance Criteria & Device Performance: The letter states that the device is "substantially equivalent" to a predicate device. It doesn't detail performance metrics or acceptance criteria for those metrics.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These are all elements of a detailed study design and results, which are not typically included in the final FDA clearance letter. The letter confirms a regulatory decision, not the scientific details of the submission's evidence.
In summary, based solely on the provided text, I cannot provide the requested details regarding acceptance criteria and the study that proves the device meets them because this information is not present in the FDA 510(k) clearance letter.
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Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three abstract shapes resembling human figures or stylized waves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 21 2004
Mr. Andrew Rowe Ouality Assurance Manager American Green Dent. Manufacturing, Incorporated 3432 E 14th Street Los Angeles, California 90023
Re: K033044
Trade/Device Name: Dream Cleans "S" Scaler and Compact "S" Scaler Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 25, 2004 Received: October 28, 2004
Dear Mr. Rowe:
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 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.
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 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.
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Page 2 - Mr. Rowe
Please be advised that FDA's issuance of a substantial equivalence determination does not I teast that FDA has made a determination that your device complies with other requirements moun that I Dr mas muss statutes and regulations administered by other Federal agencies. or the Fret of any a with all the Act's requirements, including, but not limited to: registration r ou intelst compty wart 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 et read on 1) , systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in one of radiation 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) rins leter witification. The FDA finding of substantial equivalence of your device to a premainer retirement --------------------------------------------------------------------------------------------------------------------------------------------------------your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), ' If you desire specific acroof Compliance at (240) 276-0115. 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,
Chiu 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): K033044
Device Name: Dream Cleans "S" Scaler and Dream Compact "S" Scaler
Indications For Use: The Dream Cleans "S" Scaler and Dream Compact "S" scalers are hand held ultrasonic instruments used for removal of supragingival and subgingival calculus and stains from teeth. They are also used for periodontal scaling and root planing.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Sunabunner
Civision Sian-Off) Jivision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K083044
§ 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.