ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE

K113222 · Nakamura Dental Handpiece Mfg. Co., Ltd. · EFB · Feb 23, 2012 · Dental

Device Facts

• Record ID: K113222
• Device Name: ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE
• Applicant: Nakamura Dental Handpiece Mfg. Co., Ltd.
• Product Code: EFB · Dental
• Decision Date: Feb 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

ND lowspeed airmotor, MP-50M, is used to power prophy angle attachment that helps dental clinician perform the hygiene dentistry work such as cleaning. The device is autoclavable. ND low speed airmotor, MS-10M / MS-55M, are used to power attachment that helps dental clinician perform various dental work such as cleaning, tooth carving, others. The device is autoclavable. ND star-type straight nosecone attachment, STS-30H, is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable. ND star-type contra angle attachment, STC-20L / STU-20ML / STU-30BLP, are powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable. ND highspeed airturbine handpiece, TCP-70QM / TCP-70QB / TC-80QB, are air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. The device is autoclavable.

Device Story

Device suite includes air-powered low-speed motors, high-speed air-turbine handpieces, and mechanical attachments (straight nosecones, contra-angles). Inputs: compressed air or electric power (for attachments). Operation: air-driven turbine or motor rotation transmitted to dental burs or prophy angles. Used in dental clinics by licensed clinicians. Output: mechanical rotation for dental procedures. Benefits: enables precise removal of carious material, tooth preparation, and polishing. Autoclavable for reuse.

Clinical Evidence

Bench testing only.

Technological Characteristics

Air-powered dental handpieces and attachments. Materials: autoclavable construction. Energy source: compressed air or electric micromotor. Form factor: handheld dental instruments. Connectivity: none. Sterilization: autoclavable.

Indications for Use

Indicated for dental clinicians performing hygiene, cleaning, tooth carving, cavity/crown preparation, root canal preparation, finishing, restoration, and polishing. Applicable to patients requiring dental restorative or hygiene procedures.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Shinichi Nakamura President Nakamura Dental Handpiece MFG. Company, Limited 59-2 Minami-Cho Itabashi-Ku. Tokyo Japan 173-0027

Re: K113222

Trade/Device Name: ND LOW SPEED AIRMOTOR / Model Number: MP-50M, ND LOW SPEED AIRMOTOR (SEVERAL MODELS) MS-10M / MS-55M, ND STAR-TYPE STRAIGHT NOSECONE ATTACHMENT Model Number: STS-30H, . ND STAR-TYPE CONTRA ANGLE ATTACHMENT (SEVERAL MODELS) Model Number: STC-20L / STU-20ML/ STU-35BL / STU-30BLP, ND HIGHSPEED AIRTURBINE HANDPIECE (SEVERAL MODELS) Model Number: TCP-70QM / TCP-70QB / TC-80QM / TC-80QB

Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB, EGS Dated: January 24, 2012 Received: January 30, 2012

Dear Mr. Nakamura:

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.

FEB 2 3 2012

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#### Page 2 – Mr. Nakamura

If your device is classified (see above) into either class II (Special Controls) or class III If your device it elability (000 itional controls. Existing major regulations affecting your (1 will 1), it may of our 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 mean that I Dr may Federal statutes and regulations administered by other Federal agencies. or the recording with all the Act's requirements, including, but not limited to: registration 1 ou must compt) was a 807); labeling (21 CFR Part 801); medical device reporting und ilsume (21 01 N 1 a v 0 - 7) ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . (reporting of medical as not forth in the quality systems (QS) regulation (21 CFR Part 820); production of 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), 11 you dosto http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices prems go to 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 Compilance: "First part 807.97). For questions regarding the reporting of premarket notification (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 I ou may other butter getting the mational and Consumer Assistance at its toll-free Dribber [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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510(k) Number (if known) : Device Regulation : Device Name :

K113222 21 CFR 872 4200 ND LOW SPEED AIRMOTOR Model Number : MP-50M EFB

Product Code : Indications for Use :

> ND lowspeed airmotor, MP-50M, is used to power prophy angle attachment that helps dental clinician perform the hygiene dentistry work such as cleaning. The device is autoclavable.

AND/OR Over-The-Counter Use
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K113222

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510(k) Number (if known) : Device Requlation : Device Name :

K113222 21 CFR 872 4200 ND LOW SPEED AIRMOTOR (SEVERAL MODELS) Model Number : MS-10M / MS-55M EFB

Product Code : Indications for Use :

ND low speed airmotor, MS-10M / MS-55M, are used to power attachment that helps dental clinician perform various dental work such as cleaning, tooth carving, others. The device is autoclavable.

AND/OR Over-The-Counter Use x Prescription Use (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pumpe
(Division Sign-Off)

Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: k113222

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K113222 510(k) Number (if known) : 21 CFR 872 4200 Device Regulation : ND STAR-TYPE STRAIGHT NOSECONE ATTACHMENT Device Name : Model Number : STS-30H EGS Product Code :

Indications for Use :

ND star-type straight nosecone attachment, STS-30H, is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable.

X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Penne

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K1133

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| 510(k) Number (if known) : | K113222 |
|----------------------------|-------------------------------------------------------|
| Device Regulation : | 21 CFR 872 4200 |
| Device Name : | ND STAR-TYPE CONTRA ANGLE ATTACHMENT (SEVERAL MODELS) |
| Model Number : | STC-20L / STU-20ML / STU-35BL / STU-30BLP |
| Product Code : | EGS |

Indications for Use :

ND star-type contra angle attachment, STC-20L / STU-20ML / STU-30BLP, are powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable

AND/OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ X ____________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sena Suarez

(Division Sign-Üff) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113222

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510(k) Number (if known) : Device Regulation : Device Name :

K11 322a

21 CFR 872 4200 ND HIGHSPEED AIRTURBINE HANDPIECE (SEVERAL MODELS) Model Number : TCP-70QM / TCP-70QB / TC-80QM / TC-80QB EFB

Product Code : Indications for Use :

> ND highspeed airturbine handpiece, TCP-70QM / TCP-70QB / TC-80QB, are air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. The device is autoclavable.

Prescription Use_

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

X X

(Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suze Quaser
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K111322