(263 days)
Not Found
No
The device description and intended use describe a mechanical device for cleaning teeth, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used for cleaning and polishing teeth, which are prophylactic and cosmetic procedures, not therapeutic ones.
No
Explanation: The device is described as being used for "cleaning and polishing teeth" and generates a "spray of water, air, and powder onto the tooth surface" to "clean and polish the tooth." This indicates a therapeutic or prophylactic function, not a diagnostic one.
No
The device description explicitly states it is a "hand-held device that contains air and water lines, a capped chamber for the cleaning powder, and a nozzle," which are physical hardware components.
Based on the provided information, the Bosworth Air Polisher is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Bosworth Air Polisher Function: The Bosworth Air Polisher is a dental handpiece used for cleaning and polishing teeth directly on the tooth surface. It does not analyze any specimens taken from the body.
- Intended Use: The intended use is clearly stated as "cleaning and polishing teeth," which is a physical procedure performed on the patient's tooth surface, not an in vitro analysis.
- Device Description: The description details a device that projects a spray onto the tooth surface, consistent with a physical cleaning and polishing action.
Therefore, the Bosworth Air Polisher falls under the category of a dental device used for a physical procedure, not an IVD device used for analyzing specimens.
N/A
Intended Use / Indications for Use
This device is a dental handpiece that is intended for tooth cleaning and polishing by the use of a powder, water, and air spray stream onto the tooth surface.
The Bosworth Air Polisher is a dental handpiece used for cleaning and polishing teeth. It projects a spray of water, air, and powder onto the tooth surface.
Product codes (comma separated list FDA assigned to the subject device)
EFB
Device Description
The Air Polisher is a hand-held device that contains air and water lines, a capped chamber for the cleaning powder, and a nozzle. This device connects to a standard turbine tube that supplies air and water. When the Air Polisher is connected and activated, a stream comprised of powder, air, and water spray is generated. This spray can be directed on the tooth surface to clean and polish the tooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental Professional
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)
The Bosworth Air Polisher was tested to support a minimal reuse life of 130 treatments, which corresponds to 15 hours of use. The Turbine tube connection was tested for integrity to demonstrate that the connection between the Bosworth Air Polisher and the turbine adapter, when subjected to air pressures of 47 - 53 psi, remained intact.
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
§ 872.4200 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
Attachment B
510(k) Summary for
Bosworth-Air-Polisher_
Sponsor
Harry J. Bosworth Company 7227 N. Hamlin Avenue Skokie, Illinois 60076-0399 USA
DEC - 3 2010
Establishment # 1410638
Contact Person: Gary Chuven Telephone: 1-847-679-3400 ext. 240
Date Prepared: 10 November 2010
Device Name
Proprietary Name: Common/Usual Name: Classification name: Regulation: Product code:
Bosworth Air Polisher Dental handpiece Dental handpiece and accessories 21 CFR 872.4200 EFB
Device Description
The Air Polisher is a hand-held device that contains air and water lines, a capped chamber for the cleaning powder, and a nozzle. This device connects to a standard turbine tube that supplies air and water. When the Air Polisher is connected and activated, a stream comprised of powder, air, and water spray is generated. This spray can be directed on the tooth surface to clean and polish the tooth.
Intended Use
This device is a dental handpiece that is intended for tooth cleaning and polishing by the use of a powder, water, and air spray stream onto the tooth surface.
Technological Characteristics and Substantial Equivalence
The Bosworth Air Polisher and the predicate device AirFlow Master Standard (Electro Medical Systems K073284) are used for cleaning and polishing of teeth.
1
Both the Bosworth Air Polisher and the predicate device have an identical operating principle. Projection of a powder, water, and air spray stream onto the tooth-surface-provides-the-cleaning-and-polishing-action______________________________________________________________________________________________________________________
| Comparison Item | Bosworth Prophy Gun -
Proposed | EMS Air-Flow Master
Standard - K073284 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Intended Use | Cleaning & polishing of teeth by the projection of water, air, & dental powder onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. | Air Polisher |
| Function | Air Polisher | Air Polisher |
| Cleaning &
Preparatory Action | Projection of air/water/powder mixture. | Projection of air/water/powder mixture. |
| Delivery Control | Dental operatory unit | Dedicated operational unit |
| Foot pedal Activation | Yes | Same |
| Water & Air Supply | External | Same |
| Powder Location | Powder chamber on the handpiece | Powder chamber on the operational unit |
| Prophy Powder | Bosworth Prophy Powder | Air-Flow Classic |
| Sterilization Process | Handpiece & powder nozzle: steam | Handpiece & powder nozzle: steam |
Comparison Chart for Determination of Substantial Equivalence
Performance Testing
The Bosworth Air Polisher was tested to support a minimal reuse life of 130 treatments, which corresponds to 15 hours of use. The Turbine tube connection was tested for integrity to demonstrate that the connection between the Bosworth Air Polisher and the turbine adapter, when subjected to air pressures of 47 - 53 psi, remained intact.
Conclusion Statement
Based on the comparison between the Bosworth Air Polisher and the predicate device AirFlow Master Standard, the clinical information, and on the specific testing performed on the Bosworth Air Polisher, we conclude that the Bosworth Air Polisher is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Gary Chuven Quality & Regulatory Manager Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076
Re: K100731
Trade/Device Name: Bosworth Air Polisher Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: November 15, 2010 Received: November 17, 2010
DEC - 3 2010
Dear Mr. Chuven:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2- Mr. Chuven
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
510(K) Number: K100731
Device Name: Bosworth Air Polisher
INDICATIONS FOR USE:
The Bosworth Air Polisher is a dental handpiece used for cleaning and polishing teeth. It projects a spray of water, air, and powder onto the tooth surface. The Bosworth air Polisher is designed to be used by a Dental Professional.It is a prescription device The packaging contains the following statement. "Caution: Federal law restricts this device to sale by or on the order of a Dentist. "
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR Over-the-Counter Use
Su(Optional Format 1/2/96)
(Division Sign-Off) (Division Sign-Oit)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Ansothol. Dental Devices
510(k) Number: