(77 days)
Not Found
No
The description focuses on a mechanical device for dental cleaning and does not mention any AI/ML components or functionalities.
No
The device is described as being used for dental applications to remove stains and plaque deposits from teeth, which is a prophylactic and cosmetic procedure, not a therapeutic treatment for a disease or condition. Its function is to clean and polish, rather than to treat, restore, or correct a health problem.
No
The device is used to remove stains and plaque deposits from teeth, which is a cleaning and polishing function, not a diagnostic one.
No
The device description clearly states it is a hand-held device with physical components (air and water lines, chamber, nozzle) and connects to a standard turbine tube, indicating it is a hardware device.
Based on the provided information, 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 (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The EasyProphy Series Air Polish Devices are used directly on the teeth to remove stains and plaque. They do not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "to remove stains and plaque deposits from the teeth". This is a physical cleaning process, not a diagnostic test performed on a sample.
Therefore, the function and intended use of this device fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The EasyProphy Series Air Polish Devices are intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.
Product codes
EFB
Device Description
This device 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
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental applications
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)
Testing conducted demonstrates that the easyProphy Series Air Polish Devices fulfills the prospectively defined performance specifications.
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/0 description: The image shows a series of small, dark, irregular shapes scattered across a white background. The shapes vary in size and are distributed unevenly, with some clustered together and others more isolated. The overall impression is one of randomness and contrast between the dark shapes and the bright background.
510(k) Summarv
Summary Prepared Date: 12/14/2011
Submission Sponsor:
Beyes Dental Canada Inc. 595 Middlefield Road Unit 9, Toronto, M1V 3S2 Canada
Mr. Ted Thompson Toll Free: 1-877-703-3562 info@beves.ca
Submission Correspondent:
Mr. Anthony Hopkins Regulatory Affairs Specialist
Mr. Leon Lu Director of Quality and Requlatory Affairs
MEDevice Services, LLC
3500 South Dupont Highway Dover, Delaware 19901 USA Phone: 1-877-202-1588 Fax: 1-888-202-8884 Email: medeviceservices@gmail.com www.medeviceservices.com
Trade/Device Name: EasyProphy Series Air Polish Devices, Models EasyProphy 200 and EasyProphy 400
Common or Usual Name: handpiece, air-powered, dental Device Class: I Classification Name: handpiece, air-powered, dental Requlation Number: 21 CFR 872.4200 Product Code: EFB Review Panel: Dental
1
Predicate Device:
- K032395, Nakanishi, Incorporated . Prophy-Mate
- K092289, Ems Electro Medical Systems Sa ● Ems Air-Flow Handy Perio
Device Description:
This device 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 sprav is generated. This spray can be directed on the tooth surface to clean and polish the tooth.
Intended Use:
The EasyProphy Series Air Polish Devices are intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.
Comparison to Predicate Devices:
The EasyProphy Series Air Polish Devices and the predicate device are used for cleaning and polishing of teeth. Both the proposed device and the predicate device connect to a standard turbine connection on a dental operative unit. Both deliver a mixture of water, air, and dental powder to a treatment site.
The EasyProphy Series Air Polish Devices is essentially the same as or similar to the predicate device in terms of the intended use, design and construction. performance characteristics, and materials. The patient contact materials used are well-known biocompatible, so no new issues of biocompatibility are raised with regard to this device.
Discussion of Non-Clinical Tests Performed:
Testing conducted demonstrates that the easyProphy Series Air Polish Devices fulfills the prospectively defined performance specifications.
2
Therefore, we conclude that the EasyProphy Series Air Polish Devices is both safe and effective for its intended use.
Biocompatibility:
The patient-contacting portions and waterline composition of the EasyProphy Series Air Polish Devices, Models EasyProphy 200 and EasyProphy 400 are made of type 304 Stainless Steel. Biocompatibility testing on the type 304 Stainless Steel was not performed as it is commonly used for implant device and other medical devices, and has a history of biocompatibility.
Discussion of Clinical Tests Performed:
None
Conclusion:
The EasyProphy Series Air Polish Devices as safe and effective as the predicate devices. The proposed device has the same intended uses and indications. similar technological characteristics, and principles of operation as its predicate device. The minor differences between the proposed device and its predicate devices raise no new issues of safety or effectiveness. Thus, the EasyProphy Series Air Polish Devices, models EasyProphy 200 and EasyProphy 400 are substantially equivalent to its predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES -
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Beyes Dental Canada Incorporated C/O Mr. Anthony Hopkins Regulatory Affairs Specialist MEDevice Services, LLC 3500 South Dupont Highway Dover. Delaware 19901
DEC 1 6 2011
Re: K112869
Trade/Device Name: EasyProphy Series Air Polish Devices, Models EasyProphy 200 and EasyProphy 400 Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 25, 2011 Received: September 30, 2011
Dear Mr. Hopkins:
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.
4
Page 2 - Mr. Hopkins
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 /ucm 115809.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 yours,
h 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
5
Indications for Use
510(k) Number (if known):
Device Name:
EasyProphy Series Air Polish Devices, Models EasyProphy 200 and EasyProphy 400
Indications for Use:
The EasyProphy Series Air Polish Devices are intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.
Prescription Use × Over-The-Counter Use J AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112869