TWIN POWER TURBINE 4 H is a dental handpiece. Through the tube connected to a dental unit, the handpiece of this device receives the air for high speed turbine, the cooling water for cutting treatment through pouring holes and light for illumination source. The PAR-4HEX/4HX series includes ten types of models as is shown below at Table-1, and they are be able to be connected to the coupling of the other manufacturers than J.MORITA.

AI/ML Overview

This 510(k) summary (K061701) describes a dental handpiece, the J. Morita USA Inc.'s TWIN POWER TURBINE 4H (PAR-4HEX/4HX series). The submission claims substantial equivalence to a previously cleared device (K043498), rather than providing a new study with acceptance criteria and performance data. Therefore, many of the requested details about a new study are not present in the provided text.

Here is the information that can be extracted or inferred from the document:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance for a new study are provided in this 510(k) submission. The submission asserts substantial equivalence based on similar intended uses, technological characteristics, and operating principles to a predicate device.

Acceptance Criteria	Reported Device Performance
Not applicable (No new study with distinct acceptance criteria presented)	Not applicable (No new study data presented for performance)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The submission does not describe a new study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth establishment for a test set is not mentioned as part of this substantial equivalence claim.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods for a test set are not mentioned as part of this substantial equivalence claim.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental handpiece (a physical tool), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a dental handpiece (a physical tool), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. Ground truth is not relevant for demonstrating the safety and effectiveness of a dental handpiece through a substantial equivalence claim. The equivalence is based on physical and operational characteristics compared to an existing device.

8. The sample size for the training set

Not applicable. This device is a dental handpiece and does not involve AI/machine learning, thus no training set is relevant.

9. How the ground truth for the training set was established

Not applicable. As noted in point 8, there is no training set for this device.

Summary

{0}------------------------------------------------

K061701

510(k) SUMMARY

J. MORITA USA Inc.'51 TWIN POWER TURBINE 4H

1. Submitter Name and Address with Phone/Fax:

Submitter Name and Address with Phone/Fax:
Registration No. 2081055	Registration No. 3002807636
Initial Distributor:	Manufacturer:
J. Morita USA, Inc.	J. MORITA MFG. CORP.
9 Mason	680 Higashihama Minami-cho
Irvine, CA 92618	Fushimi-ku, Kyoto
USA	Japan 612-8533
Telephone:949-581-9600	+81-75-611-2141
Facsimile:949-581-9688	+81-75-605-2354

Contact Person: 2.

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite: 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
May 15, 2006 Date summary prepared: 3.
1. Device Name:
  .

Trade or Proprietary Name::	TWIN POWER TURBINE 4H (High Speed Air Turbine Dental Handpiece)
Models;	PAR-4HEX/4HX series (Details are listed at Table-1 in page 3 of this submission.)
Common Name:	Air powered dental handpiece
Classification Name:	Dental handpiece and accessories (21CFR 872.4200 )
Product Code :	EFB ( "Handpiece, Air-powered, Dental ")

Substantial Equivalency is claimed against the following device: ડ.

PAR-4HE-O of J. MORITA MFG. CORP.( K043498)

{1}------------------------------------------------

6. Description of the device:

VI-1 DEVICE DESCRIPTION

TWIN POWER TURBINE 4 H is a dental handpiece.

Through the tube connected to a dental unit, the handpiece of this device receives the air for high speed turbine, the cooling water for cutting treatment through pouring holes and light for illumination source.

The PAR-4HEX/4HX series includes ten types of models as is shown below at Table-1, and they are be able to be connected to the coupling of the other manufacturers than J.MORITA .

Table-1Name	Model	Main Body		Coupling
		Body	Headassembly	PAR- 4 Holecoupling	TubeconnectionISO9168
TWINPOWERTURBINE4 H	PAR- 4 HEX-O	PAR- 4 HEX-O	Standardtype	JMORITA MFG. CORP.CP4-O, CP4-WO,CP4-CS-O	Type-Cin case of"withlight"
	PAR- 4 HEX-O-KV	PAR- 4 HEX-O-KV-		KAVOMULTIflex,MULTIflex LUX
	PAR- 4 HEX-O-NK	PAR- 4 HEX-O-NK		NSKPhatelus coupling
	PAR- 4 HEX-O-SR	PAR-4 HEX-O-SR		SIRONAR/F coupling
	PAR- 4 HEX-O-WH	PAR- 4 HEX-O-WH		W&HRoto Quick coupling
	PAR- 4 HX-O	PAR- 4 HX-O		JMORITA MFG. CORP.CP4-O, CP4-WO,CP4-CS-O
	PAR- 4 HX-O-KV	PAR- 4 HX-O-KV	Torque-uptype	KAVOMULTIflex,MULTIflex LUX	Type-Bin case of"withoutlight"
	PAR- 4 HX-O-NK	PAR- 4 HX-O-NK		NSKPhatelus coupling
	PAR- 4 HX-O- SR	PAR- 4 HX-O-SR		SIRONAR/F coupling
	PAR- 4 HX-O-WH	PAR- 4 HX-O-WH		W&HRoto Quick coupling

Table-1 PAR-4HEX/4HX series

NOTE:

Suffix "-O" is a sign for " with light" .

There are models without light in the series whose suffix "-O" is removed away from the name. For example, PAR .- 4 HX-O- KV is " with light" and PAR-4 HX- KV is "without light", and so on. It is also applicable for the names of PAR- 4 Hole coupling made by JMORITA such as CP4-O, CP4-WO or CP4-CS-O ( with light) and CP4, CP4-W or CP4-CS ( without light).

Suffix "-ML" is attached to the model name when the metal ball bearing is assembled in the handpiece, for instance, PAR- 4 HX-O- KV-ML or so.

{2}------------------------------------------------

Indications for Use 7.

The PAR-4HEX/ 4 HX series handpiece is for use by authorized persons in the practice of the dentistry.

Safety and effectiveness of the device 8.

is only slightly modified from our Previous PAR- 4 H TWIN POWER TURBINE ( K043498) , by adding some new phases such as;.

Coupling

. Coupling
This new model is able to be connected to the coupling manufactured and/or distributed by the the other model is able to be ben the coupling of J. MORITA MFG. CORP.

the other manufacturers more than the objaction, is added on the previous specifications.

However, the PAR-4HEX/4HX series is substantially equivalent to our previous PAR-4H because they have similar general intended uses, technological series ( K043498) characteristics and operating principles.

aracteristics and operating principies.
Any differences in the technological characteristics do not raise any new issues of safety or effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle, with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Attorney Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005

AUG 2 5 2006

Re: K061701

Trade/Device Name: PAR-4HEX/HX Series Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: June 15, 2006 Received: June 16, 2006

Dear Mr. Barritt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Barritt

. -

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Sybilte Y. Mcchain Orrs

Chiu Lin, Ph.D. 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):

unknown K061701.

Device Name:

PAR-4HEX/HX series handpiece

Indications For Use:

The PAR-4HEX/4HX series handpiece is for use by authorizéd persons in the practice of the dentistry.

Prescription Use (Part 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 CDRH, Office of Device Evaluation (ODE)

Suza Ruoy

1 : Jan-Off) n of Anesthesiology, General Hospital, Page 1 of on Control. Dental Devices

Number: `KC6170

077

Regulation Number and Section

§ 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.