(84 days)
Not Found
No
The device description and intended use clearly describe a dental prophy powder and its use in air polishing units, with no mention of AI or ML capabilities.
No.
The device is used for cleaning, polishing, and restoring the natural esthetics of tooth enamel, which aligns with cosmetic or maintenance purposes rather than treating or preventing a disease or condition.
No
The device description clearly states its purpose is for "cleaning, polishing and restoring the natural esthetics of tooth enamel," which describes a therapeutic or cosmetic function rather than a diagnostic one. There is no mention of identifying, detecting, or measuring a medical condition.
No
The device description clearly states it is a "NEW PROPHY POWDER" which is a physical substance used in dental air polishing units, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cleaning, polishing and restoring the natural esthetics of tooth enamel." This is a direct treatment or cosmetic procedure performed on the tooth surface, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a "NEW PROPHY POWDER" used in dental air polishing units. It produces a spray mixture for cleaning and polishing teeth. This is a physical action on the tooth, not a test to detect or measure substances in a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
For use with all DENTSPLY® Cavitron™ Prophy-Jet® Systems and DENTSPLY® Cavitron-Jet™ Systems for cleaning, polishing and restoring the natural esthetics of tooth enamel.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
NEW PROPHY POWDER is for use in DENTSPLY dental air polishing units. When the air polishing unit is in the JET mode, it produces a spray mixture of air, water, and powder to clean, polish and restore the natural esthetics of tooth enamel. NEW PROPHY POWDER is a new formulation and is for use with all DENTSPLY® Cavitron™ Prophy-Jet® Systems and DENTSPLY® Cavitron-Jet™ Systems. NEW PROPHY POWDER will be offered in two size bottle/closure for sampling and an 8-oz. bottle/closure as standard). The bottles will have a wide mouth for easy dispensing and be packaged as six bottles per shipper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth enamel
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6080 Airbrush.
(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”
0
510(k) SUMMARY
MAR 1 5 2002
DENTSPLY
NAME & ADDRESS:
DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 717) 845-7511 For 1717 849 4762
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
December 20,2001 DATE PREPARED:
NEW PROPHY POWDER TRADE OR PROPRIETARY NAME:
CLASSIFICATION NAME: Airbrush (ACCESSORY) 872.6080
PREDICATE DEVICES: Accessory to Cavitron Jet with SPS System K970342
DEVICE DESCRIPTION: NEW PROPHY POWDER is for use in DENTSPLY dental air polishing units. When the air polishing unit is in the JET mode, it produces a spray mixture of air, water, and powder to clean, polish and restore the natural esthetics of tooth enamel. NEW PROPHY POWDER is a new formulation and is for use with all DENTSPLY® Cavitron™ Prophy-Jet® Systems and DENTSPLY® Cavitron-Jet™ Systems. NEW PROPHY POWDER will be offered in two size bottle/closure for sampling and an 8-oz. bottle/closure as standard). The bottles will have a wide mouth for easy dispensing and be packaged as six bottles per shipper.
For use with all DENTSPLY® Cavitron™ Prophy-Jet® Systems and INTENDED USE: DENTSPLY® Cavitron-Jet™ Systems for cleaning, polishing and restoring the natural esthetics of tooth enamel.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in NEW PROPHY POWDER have been used in legally marketed devices or were found safe for dental use.
NEW PROPHY POWDER has been evaluated and passed biocompatibility testing for cytotoxicity, acute oral toxicity, irritation, and sensitization.
We believe that the prior use of the components of NEW PROPHY POWDER in the legally marketed predicate device, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of NEW PROPHY POWDER for the indicated William.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's wings and head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2002
Mr. P. Jeffery Lehn Director, Corporate Compliance & Regulatory Affairs Dentsply International 570 West College Avenue York, Pennsylvania 17404
Re: K014188
Trade/Device Name: New Prophy Powder Regulation Number: 872.4850 Regulation Name: Accessory to Dental Prophylaxis Units Regulatory Class: II Product Code: ELC Dated: December 20, 2001 Received: December 21, 2001
Dear Mr. Lehn:
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.
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.
2
Page 2 - Mr. Lehn
You must comply with all the Act's requirements, including, but not limited to: registration 1 ou must comply with an the Hood Song (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 077), lastimos (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify 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 This letter will anow you to begin inaling of substantial equivalence of your device to 310(K) promative nouricate 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 II you desire specific da 1.00 for in vitro diagnostic devices), please contact the and additionally 21 OF 1 301) 594-4613. Additionally, for questions on the promotion and Office of Colliphance at (301) as contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Anotification" (21CFR Part 807.97). Other general information on your responsibilities under noutheation (21 OF ICP of It is a from the Division of Small Manufacturers, International and the Act may of obtained 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,
A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known): KC14188
NEW PROPHY POWDER Device Name:
Indications for Use:
For use with all DENTSPLY® Cavitron™ Prophy-Jet® Systems and DENTSPLY® Cavitron-Jet™ Systems for cleaning, polishing and restoring the natural esthetics of tooth enamel.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
1 Number K014188 ver-The-Counter Use
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
(Optional Format 1-2-96)