(146 days)
Not Defined
No
The description details a mechanical device for tooth polishing and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is used for cleaning and preparing tooth surfaces for bonding and sealants, which are considered dental procedures, not therapeutic interventions aimed at curing, treating, or preventing disease.
No
The device is used to remove stains and plaque, prepare surfaces for bonding, and prepare for pit and fissure sealant. These are all treatment or preparation functions, not diagnostic ones.
No
The device description clearly states it is an "air-powered tooth polishing system" consisting of physical components like a powder case, handpiece, and nozzles, indicating it is a hardware device.
Based on the provided information, the Prophy-Mate Neo device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove stains and plaque from teeth, prepare surfaces for bonding, and prepare for pit and fissure sealants. These are all procedures performed directly on the patient's teeth, not on samples taken from the body.
- Device Description: The device description details a system that expels a mixture of powders, water, and air onto tooth surfaces. This is a physical action performed externally on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Prophy-Mate Neo's function is purely mechanical and external to the body.
N/A
Intended Use / Indications for Use
The Prophy-Mate Neo device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powders or calcium carbonate powders, air, and water onto tooth surfaces.
The Prophy-Mate neo can also be used in dental applications to prepare surface prior to bonding and to prepare for pit and fissure sealant.
Product codes
EFB
Device Description
The Prophy-Mate neo is an air-powered tooth polishing system. The product expels a mixture of powders (sodium bicarbonate or calcium carbonate), water, and air onto the surfaces of the tooth. The Prophy-Mate neo consists of the Powder case, Handpiece, with a 60° and 80° Nozzle attachment.
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)
The Prophy-Mate neo was developed and is produced under consideration of all applicable technical standards, and internal specifications. The product's conformance with applicable international and internal standards was verified in the course of bench testing.
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
5. 510(k) SUMMARY
| Submitter: | Nakanishi, Inc.
700 Shimohinata
Kanuma-Shi, Tochigi-Ken Japan 322-8666 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Toshihiko Shinozaki
Assistant Manager, R&D Dept. Pharmaceutical Affairs Gr.
TEL: 0289(64)3380
FAX: 0289(62)6665
t-shinozaki@nsk-nakanishi.co.jp |
| Date Prepared: | January 26, 2012 |
| Trade Name: | Prophy-Mate neo |
| Common Name: | Air Powered Tooth Polishing System |
| Classification Name: | EFB 872.4200 Handpiece, Air-Powered, Dental |
| Predicate Device: | K032395 - Prophy-Mate
K973876 - Prophyflex2, Model 2012
K022119 - EMS AIR-FLOW® handy 2 |
| Device Description: | The Prophy-Mate neo is an air-powered tooth polishing system. The product expels
a mixture of powders (sodium bicarbonate or calcium carbonate), water, and air
onto the surfaces of the tooth. The Prophy-Mate neo consists of the Powder case,
Handpiece, with a 60° and 80° Nozzle attachment. |
| Statement of
Intended Use: | The Prophy-Mate Neo device is intended for use in dental applications to remove
stains and plaque deposits from the teeth by shooting a mixture of sodium
bicarbonate powders or calcium carbonate powders, air, and water onto tooth
surfaces.
Sodium bicarbonate should not be used on patients on a saltless diet, with a renal deficiency, with a chronic respiratory disease, or with chronic diarrhea.
The Prophy-Mate neo can also be used in dental applications to prepare surface
prior to bonding and to prepare for pit and fissure sealant. |
| Summary of
Technological
Characteristics: | The 360° twist free swivel joint at the handpiece end and the hose end of the
powder case enables smooth operation even under high air pressure. The handpiece
swivels so easily that access to hard to reach areas becomes effortless. The
Prophy-Mate neo is designed to minimize stain and fatigue even during prolonged operation
The choice of nozzle between 60° and 80° enables easy reach of all tooth surfaces and unobstructed vision. |
月112673
FEB - 7 2012
: ... .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Section 5: Page 1 of 2
1
Performance Testing: applicable technical
The Prophy-Mate neo was developed and is produced under consideration of all standards, and internal specifications. The product's conformance with applicable international and internal standards was verified in the course of bench testing.
Conclusion:
Nakanishi considers the Prophy-Mate neo to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in intended use, principles of operation, functional design, and established medical use, and does not raise new issues of safety and effectiveness.
Image /page/1/Picture/4 description: The image shows a black and white drawing of a bird. The bird is in flight, with its wings spread and its head turned to the side. The bird's feathers are detailed, and its beak is sharp. The background is plain white, which helps to emphasize the bird.
Section 5: Page 2 of 2
NAKANISHI INC. www.nsk-inc.com
Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan Tokyo Office : MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which features a staff with a serpent entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nakanishi. Incorporated Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 Richardson, Texas 75080
Re: K112673
Trade/Device Name: Prophy-Mate neo Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: January 26, 2012 Received: February 1, 2012
Dear Ms. Rutherford:
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.
FEB - 7 2012
3
Page 2 – Ms. Rutherford
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
INDICATIONS FOR USE
510(k) Number: 1212673
Device Name: Prophy-Mate neo
Indications for Use:
The Prophy-Mate Neo device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powders or calcium carbonate powders, air, and water onto tooth surfaces.
The Prophy-Mate neo can also be used in dental applications to prepare surface prior to bonding and to prepare for pit and fissure sealant.
Prescription Use _ X (21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDHR, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K112673 |
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