(22 days)
Not Found
No
The device description and intended use are purely mechanical/chemical, and there are no mentions of AI, ML, or related concepts.
No
The device is described as a powder for removing plaque and stains, which falls under general dentistry rather than therapeutic treatment for a disease or condition.
No
Explanation: The device is intended for removing plaque deposits and stains from teeth, which is a treatment or cleaning function, not a diagnostic one.
No
The device is a powder intended for use with a dental device, which is a physical substance and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The PROPHYpearls device is used to physically remove plaque and stains from the surface of teeth. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use clearly states its purpose is for "removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces." This is a mechanical cleaning process, not a diagnostic test.
Therefore, based on the provided information, the PROPHYpearls device is a dental device used for cleaning, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
PROPHYpearls is a powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces.
Product codes
EFB, EJR
Device Description
This submission is for a modification of a device system cleared under K973876, the PROPHYflex 2 Dental Device. The predicate system consists of a handpiece and powder combination which is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The modification involves changing the powder from sodium bicarbonate to calcium carbonate. Calcium carbonate is a substance which is inherently biocompatible, and studies have shown that the calcium carbonate powder does an equal or better job of removing plaque. Calcium carbonate is recognized in the Code of Federal Regulations as a food substance generally recognized as safe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Studies have shown that the calcium carbonate powder does an equal or better job of removing plaque.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/1 description: The image shows a series of handwritten numbers and letters. The characters appear to be "K031868". The writing style is somewhat rough, giving the impression of being quickly jotted down.
EXHIBIT 2 KaVo America Corporation 340 East Main Street Lake Zurich, Illinois 60047 Toll Free: 800 323 8029 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 e-mail: info@kavousa.com Contact: John Franz, President June 12, 2003 510(k) Summary of Safety and Effectiveness
- Identification of the Device: 1. Proprietary-Trade Name: KaVo PROPHYpearls Classification Name: HANDPIECE, AIR-POWERED, DENTAL, Product Code EFB Common/Usual Name: Cleaning powder for use with dental handpiece
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- Equivalent legally marketed device: This product is similar in design and identical in function to PROPHYflex 2 (K973876) (powder).
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- Indications for Use (intended use): PROPHYpearls is a powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces.
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- Description of the Device: This submission is for a modification of a device system cleared under K973876, the PROPHYflex 2 Dental Device. The predicate system consists of a handpiece and powder combination which is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The modification involves changing the powder from sodium bicarbonate to calcium carbonate. Calcium carbonate is a substance which is inherently biocompatible, and studies have shown that the calcium carbonate powder does an equal or better job of removing plaque. Calcium carbonate is recognized in the Code of Federal Regulations as a food substance generally recognized as safe.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
9 2003 JUL
KaVo America Corporation C/O Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K031868
Trade/Device Name: PROPHYpearls Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Codes: EJR, EFB Dated: June 16, 2003 Received: June 26, 2003
Dear Mr. Kamm:
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 - Daniel Kamm, P.E.
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product 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) premarket notification. The FDA finding of substantial equivalence 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), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division 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,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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j) Indications for Use
510(k) Number
Device Name: .
Indications for Use: PROPHYpearls is a powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Over the Counter Use_ Prescription Use OR (Per 21 CFR 801.109)
Ken Ruby for MSR
hesiology. General Hospital.
510(k) Number: K 031868