(449 days)
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Not Found
No
The summary describes a standard ultrasonic scaler and does not mention any AI or ML capabilities.
Yes
The device is used for "removal of supragingival and subgingival calculus and stains from teeth" and "periodontal scaling and root planing," which are therapeutic dental procedures.
No
Explanation: The device is described as an ultrasonic instrument for removing calculus and stains and for periodontal scaling and root planing, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it is a "hand held ultrasonic instrument," indicating a physical hardware component.
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 a hand-held ultrasonic instrument used for removing calculus and stains from teeth, as well as for periodontal scaling and root planing. These are procedures performed directly on the patient's teeth, not on samples taken from the body.
- Device Description: The description confirms it's a hand-held ultrasonic instrument, reinforcing its use in direct patient care.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting diseases or conditions based on in vitro analysis, or any other activities typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely mechanical and therapeutic, performed directly on the patient's teeth.
N/A
Intended Use / 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.
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
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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.
0
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.
1
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
2
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