(70 days)
Not Found
No
The 510(k) summary describes a standard dental handpiece and does not mention any AI or ML capabilities.
No
The device is a dental handpiece used for cutting treatment, which is a surgical tool, not a therapeutic device.
No
This device is described as a "dental handpiece" used for "cutting treatment" and providing "illumination source." Its intended use is by authorized persons "in the practice of the dentistry," implying a therapeutic or procedural function rather than a diagnostic one.
No
The device description explicitly states it is a "dental handpiece" and describes physical components like tubes, a turbine, cooling water holes, and a light source, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use by authorized persons in the practice of the dentistry." This describes a device used directly on a patient for dental procedures, not for testing samples outside the body.
- Device Description: The description details a "dental handpiece" that receives air, water, and light for cutting treatment. This is a mechanical tool used in dental procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental handpiece does not fit that description.
N/A
Intended Use / Indications for Use
The PAR-4HEX/ 4 HX series handpiece is for use by authorized persons in the practice of the dentistry.
Product codes (comma separated list FDA assigned to the subject device)
EFB, EFA
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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
authorized persons in the practice of the dentistry.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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. -
- Device Name:
.
- 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-1
| Name | Model | Main Body | Coupling | ||
|---|---|---|---|---|---|
| Body | Head | ||||
| assembly | PAR- 4 Hole | ||||
| coupling | Tube | ||||
| connection | |||||
| ISO9168 | |||||
| TWIN | |||||
| POWER | |||||
| TURBINE | |||||
| 4 H | PAR- 4 HEX-O | PAR- 4 HEX-O | Standard | ||
| type | JMORITA MFG. CORP. | ||||
| CP4-O, CP4-WO, | |||||
| CP4-CS-O | Type-C | ||||
| in case of | |||||
| "with | |||||
| light" | |||||
| PAR- 4 HEX-O- | |||||
| KV | PAR- 4 HEX-O- | ||||
| KV- | KAVO | ||||
| MULTIflex, | |||||
| MULTIflex LUX | |||||
| PAR- 4 HEX-O- | |||||
| NK | PAR- 4 HEX-O- | ||||
| NK | NSK | ||||
| Phatelus coupling | |||||
| PAR- 4 HEX-O-SR | PAR-4 HEX-O- | ||||
| SR | SIRONA | ||||
| R/F coupling | |||||
| PAR- 4 HEX-O- | |||||
| WH | PAR- 4 HEX-O- | ||||
| WH | W&H | ||||
| Roto 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-up | ||||
| type | KAVO | ||||
| MULTIflex, | |||||
| MULTIflex LUX | Type-B | ||||
| in case of | |||||
| "without | |||||
| light" | |||||
| PAR- 4 HX-O-NK | PAR- 4 HX-O- | ||||
| NK | NSK | ||||
| Phatelus coupling | |||||
| PAR- 4 HX-O- SR | PAR- 4 HX-O- | ||||
| SR | SIRONA | ||||
| R/F coupling | |||||
| PAR- 4 HX-O-WH | PAR- 4 HX-O- | ||||
| WH | W&H | ||||
| Roto 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