PROPHY-MATE NEO

K112673 · Nakanishi, Inc. · EFB · Feb 7, 2012 · Dental

Device Facts

• Record ID: K112673
• Device Name: PROPHY-MATE NEO
• Applicant: Nakanishi, Inc.
• Product Code: EFB · Dental
• Decision Date: Feb 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

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.

Device Story

Air-powered dental polishing system; expels mixture of powder (sodium bicarbonate or calcium carbonate), water, and air onto tooth surfaces. Used by dental professionals in clinical settings. Features 360° twist-free swivel joint at handpiece and powder case hose end; includes 60° and 80° nozzle attachments for improved access to tooth surfaces and visibility. Device removes stains/plaque and prepares surfaces for bonding/sealants. Benefits include reduced operator fatigue and improved access to hard-to-reach areas.

Clinical Evidence

Bench testing only. Conformance with applicable international and internal standards verified via bench testing.

Technological Characteristics

Air-powered dental handpiece; 360° twist-free swivel joint; 60° and 80° nozzle attachments. Operates via pneumatic delivery of powder/water/air mixture. No software or electronic components.

Indications for Use

Indicated for dental patients requiring removal of stains and plaque, or surface preparation for bonding and pit/fissure sealants. Contraindicated for sodium bicarbonate use in patients on saltless diets, or those with renal deficiency, chronic respiratory disease, or chronic diarrhea.

Regulatory Classification

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.

Predicate Devices

• Prophy-Mate (K032395)
• Prophyflex2, Model 2012 (K973876)
• EMS AIR-FLOW® handy 2 (K022119)

Submission Summary (Full Text)

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## 5. 510(k) SUMMARY

| Submitter: | Nakanishi, Inc.<br>700 Shimohinata<br>Kanuma-Shi, Tochigi-Ken Japan 322-8666 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Toshihiko Shinozaki<br>Assistant Manager, R&D Dept. Pharmaceutical Affairs Gr.<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] |
| 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<br>K973876 - Prophyflex2, Model 2012<br>K022119 - EMS AIR-FLOW® handy 2 |
| Device Description: | The Prophy-Mate neo is an air-powered tooth polishing system. The product expels<br>a mixture of powders (sodium bicarbonate or calcium carbonate), water, and air<br>onto the surfaces of the tooth. The Prophy-Mate neo consists of the Powder case,<br>Handpiece, with a 60° and 80° Nozzle attachment. |
| Statement of<br>Intended Use: | The Prophy-Mate Neo device is intended for use in dental applications to remove<br>stains and plaque deposits from the teeth by shooting a mixture of sodium<br>bicarbonate powders or calcium carbonate powders, air, and water onto tooth<br>surfaces.<br>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.<br>The Prophy-Mate neo can also be used in dental applications to prepare surface<br>prior to bonding and to prepare for pit and fissure sealant. |
| Summary of<br>Technological<br>Characteristics: | The 360° twist free swivel joint at the handpiece end and the hose end of the<br>powder case enables smooth operation even under high air pressure. The handpiece<br>swivels so easily that access to hard to reach areas becomes effortless. The<br>Prophy-Mate neo is designed to minimize stain and fatigue even during prolonged operation<br>The choice of nozzle between 60° and 80° enables easy reach of all tooth surfaces and unobstructed vision. |

月112673

FEB - 7 2012

www.nsk-inc.com

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Section 5: Page 1 of 2

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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.

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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

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#### 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

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### 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 [phone] or [phone] 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

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#### 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<br>Infection Control, Dental Devices | |
| 510(k) Number: | K112673 |

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