(540 days)
No
The device description and performance studies focus on mechanical and physical properties (rotation speed, torque, noise level, pressure, sterilization, biocompatibility) of a dental handpiece and coupling, with no mention of AI or ML.
Yes
The device is described as a dental handpiece used for various dental procedures such as caries removal and cavity preparation, which are direct interventions for treating conditions in the body.
No
Explanation: The device is intended for caries removal, cavity and crown preparation, removal of dental restorations, and finishing of teeth and dental restorations, which are all treatment-oriented procedures, not diagnostic ones.
No
The device description clearly details physical, air-driven dental handpieces and couplings, which are hardware components. The performance studies also focus on bench testing and compliance with standards related to physical device characteristics like sterilization, biocompatibility, and mechanical performance (rotation speed, torque, noise level).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's teeth (caries removal, cavity preparation, etc.). IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device is a dental handpiece used for mechanical procedures in the mouth. It does not involve the analysis of biological samples.
- Anatomical Site: The anatomical site is "teeth," which are part of the patient's body, not a specimen being tested.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on laboratory testing.
This device is a dental instrument used for treatment and preparation within the oral cavity.
N/A
Intended Use / Indications for Use
The Stainless Turbine is intended for the following applications: Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment). The coupling is intended for the following applications: A connection device to transfer energy (air, water, light) required for handpieces.
Product codes
EFB
Device Description
The Stainless Turbine handpieces are air driven dental handpieces for use by a trained professional in the field of general dentistry. The handpieces are air-powered, high-speed dental handpieces capable of reaching rotational speeds of 325,000 to 450,000 revolutions per minute. Handpiece models include fiber optic, LED, and non-optic lighting. The handpiece models are available to connect directly to NAKANISHI INC. manufactured couplings. Available handpiece models include the S-Max M Series, Pana-Max Plus Series, Pana-Max Plus2 Series, and the S-Max pico Series. The Stainless Turbine couplings are connection devices used to attach the dental unit to the Stainless Turbine handpieces. Available coupling models include the Glass Fiber Rod Series, LED Series, and No Light Irradiation Series.
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
trained professional in the field of general 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)
The Stainless Turbine handpieces and couplings were developed and are produced under the consideration of all applicable technical standards, internal specifications, and FDA guidance documents. The devices' conformance with applicable international and internal standards was verified over the course of bench testing. Tests were performed on the handpieces including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent to FDA cleared devices. Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of Health Care Products – Moist Heat - Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. Documentation was provided demonstrating that the Stainless Turbine handpieces and couplings comply with the requirements stated in the FDA guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff. Biocompatibility evaluations were selected in accordance with ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing and the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and Testing. In addition. testing for performance of the handpieces was conducted in accordance with ISO 14457:2012 Dentistry - Handpieces and motors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
June 21, 2022
NAKANISHI INC. % Kelby Villarreal Biomedical Engineer Ken Block Consulting LLC 800 East Campbell Road, Suite 202 Richardson. Texas 75081
Re: K203791
Trade/Device Name: Stainless Turbine Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: May 20, 2022 Received: May 23, 2022
Dear Kelby Villarreal:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203791
Device Name Stainless Turbine
Indications for Use (Describe)
The Stainless Turbine is intended for the following applications:
Caries removal, Cavity and crown preparation, Removal of dental restorations (fillings and prostheses), Finishing of teeth and dental restorations (preparation/adjustment).
The coupling is intended for the following applications: A connection device to transfer energy (air, water, light) required for handpieces.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| 510(k) SUMMARY | K203791 | |
|---|---|---|
| Submitter: | NAKANISHI INC. | |
| 700 Shimohinata | ||
| Kanuma Tochigi 322-8666 Japan | ||
| Contact Person: | Mr. Masaaki Kikuchi | |
| General Manager, Regulatory Affairs Dept. | ||
| TEL: +81-289-64-7277 | ||
| FAX: +81-289-62-9738 | ||
| m-kikuchi@nsk-nakanishi.co.jp | ||
| Date Prepared: | June 17, 2022 | |
| Submission Type: | Traditional 510(k) | |
| Subject Device: | Clearance: | |
| Manufacturer: | ||
| Trade Name: | ||
| Common Name: | ||
| Regulatory Class: | ||
| Classification Name: | ||
| Product Code: | ||
| Regulation: | K203791 | |
| NAKANISHI INC. | ||
| Stainless Turbine | ||
| Handpiece, Air-Powered, Dental | ||
| Class I | ||
| Dental handpiece and accessories | ||
| EFB | ||
| 872.4200 | ||
| Primary | ||
| Predicate Device: | Clearance: | |
| Manufacturer: | ||
| Trade Name: | ||
| Common Name: | ||
| Regulatory Class: | ||
| Classification Name: | ||
| Product Code: | ||
| Regulation: | K131319 | |
| Sirona Dental Systems GmbH | ||
| T1 / T2 / T3 Turbine family with serial no. > 600,000 | ||
| Handpiece, Air-Powered, Dental | ||
| Class I | ||
| Dental handpiece and accessories | ||
| EFB | ||
| 872.4200 | ||
| Secondary | ||
| Predicate Device: | Clearance: | |
| Manufacturer: | ||
| Trade Name: | ||
| Common Name: | ||
| Regulatory Class: | ||
| Classification Name: | ||
| Product Code: | ||
| Regulation: | K112024 | |
| NAKANISHI INC. | ||
| Ti-Max X450 | ||
| Handpiece, Air-Powered, Dental | ||
| Class I | ||
| Dental handpiece and accessories | ||
| EFB | ||
| 872.4200 | ||
| 510(k) SUMMARY | K203791 | |
| Reference Device: Clearance: | K980162 | |
| Manufacturer: | NAKANISHI INC. | |
| Trade Name: | Mach-Sigma Handpiece, Ultrapush | |
| Common Name: | Handpiece, Air-Powered, Dental | |
| Regulatory Class: | Class I | |
| Classification Name: | Dental handpiece and accessories | |
| Product Code: | EFB | |
| Regulation: | 872.4200 | |
| Reference Device: Clearance: | K991701 | |
| Manufacturer: | NAKANISHI INC. | |
| Trade Name: | Mach-Sigma Handpiece, Ultrapush, Models Mach-Sigma | |
| MU (Minihead), Mach-Sigma SU (Standard Head), Mach- | ||
| Sigma TU (Torque Head) | ||
| Common Name: | Handpiece, Air-Powered, Dental | |
| Regulatory Class: | Class I | |
| Classification Name: | Dental handpiece and accessories | |
| Product Code: | EFB | |
| Regulation: | 872.4200 | |
| Device | ||
| Description: | The Stainless Turbine handpieces are air driven dental handpieces for use by a trained | |
| professional in the field of general dentistry. The handpieces are air-powered, high- | ||
| speed dental handpieces capable of reaching rotational speeds of 325,000 to 450,000 | ||
| revolutions per minute. Handpiece models include fiber optic, LED, and non-optic | ||
| lighting. The handpiece models are available to connect directly to NAKANISHI INC. | ||
| manufactured couplings. Available handpiece models include the S-Max M Series, | ||
| Pana-Max Plus Series, Pana-Max Plus2 Series, and the S-Max pico Series. The | ||
| Stainless Turbine couplings are connection devices used to attach the dental unit to | ||
| the Stainless Turbine handpieces. Available coupling models include the Glass Fiber | ||
| Rod Series, LED Series, and No Light Irradiation Series. | ||
| Indications for | ||
| Use: | The Stainless Turbine is intended for the following applications: Caries removal, | |
| Cavity and crown preparation, Removal of dental restorations (fillings and | ||
| prostheses), Finishing of teeth and dental restorations (preparation/adjustment). | ||
| The coupling is intended for the following applications: A connection device to | ||
| transfer energy (air, water, light) required for handpieces. |
Page 1 of 11 NAKANISHI INC.
4
Summary of The Stainless Turbine handpieces are intended for use with a friction grip bur that Technological conforms to ISO 1797-1 standard. The handpieces are capable of achieving rotational Characteristics: speeds of 325,000 to 450,000 revolutions per minute when provided with a supply air pressure of 0.18 to 0.30 MPa. This provides a torque of at least 0.05 N·cm, while
5
K203791
generating a noise level of 80 dBA or less. All models include an air-water spray feature that is directed to the bur in order to cool down the operating area.
The Stainless Turbine handpiece models of the S-Max M and S-Max pico series have a one-touch quick connect coupling system that allows for the attachment of couplings to the handpieces. When the handpiece and coupling are joined together, a locking mechanism functions to prevent the handpiece from being removed from the coupling during use. The connection mechanism of the handpiece and coupling also has a swivel adapter which allows the handpiece to swivel when connected to the coupling and dental unit. The coupling and hose of the dental unit will be connected using a 5-, 4-, 3-, or 2-hole connector that meets ISO 9168 specifications. The Stainless Turbine handpieces of the Pana-Max Plus and Pana-Max Plus2 series connect directly to the hose of the dental unit. Direct connection to the dental unit can be made with a 4-hole connection that also meets ISO 9168 specifications.
All Stainless Turbine handpieces are equipped with a Clean Head System (CHS). which is intended to reduce the ingress of foreign matter into the handpiece, and all Stainless Turbine couplings have an integrated Anti-Retraction Valve (ARV), which is intended to help reduce cross-contamination in the water lines of the handpiece and dental unit.
Tables 1 and 2 provide a comparison of the proposed device to both the predicate and reference devices. The tables illustrate the similarities and difference between the devices.
6
K203791
| | Proposed
Device | Primary
Predicate | Secondary
Predicate |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Stainless Turbine | T1 / T2 / T3
Turbine family
with serial no. >
600,000 | Ti-Max X450 |
| 510(k)
Submitter
[Number] | NAKANISHI INC.
[K203791] | Sirona Dental
Systems GmbH
[K131319] | NAKANISHI INC.
[K112024] |
| Indications for
Use | The Stainless Turbine
is intended for the
following applications:
Caries removal, Cavity
and crown preparation,
Removal of dental
restorations (fillings
and prostheses),
Finishing of teeth and
dental restorations
(preparation /
adjustment).
The Coupling is
intended for the
following applications:
A connection device to
transfer energy (air,
water, light) required
for handpieces. | The turbines of the
T1 / T2 / T3
Turbine family are
intended for the
Preparation of
cavities and
crowns, Removal
of carious
material, Removal
of fillings,
Processing of
tooth and
restoration
surfaces, Reducing
hard tooth
structure. | The Ti-Max X450 is
an air-powered
dental handpiece
with intended use of
being a surgical tool
for impacted third
molar removal and
periodontal
procedures for
which a
conventional
handpiece would be
used. The Ti-Max
X450 is intended for
use with a friction
grip bur that
conforms to ISO
1797-1 standard.
Recommended
supply air pressure
is between 0.22 and
0.30 MPa, which
results in high speed
bur rotation
(approximately
380,000 to 450,000
RPM). |
| Model Numbers | Handpiece Series
S-Max M:
M500, M500L,
M500K, M500KL,
M500SL, M600,
M600L, M600K,
M600KL, M600SL,
M600WLED, M800,
M800L, M800KL,
M800WL, M900,
M900L, M900K, | T1 Turbines
T1 Control:
T1 Control S,
T1 Control K,
T1 Control W,
T1 Control N
T1 Boost:
T1 Boost S,
T1 Boost K,
T1 Boost W,
T1 Boost N | X450L, X450KL,
X450SL, X450STL,
X450WHL,
X450MWL,
X450M4, X450,
X450 5H,
X450BLED,
X450WLED |
| | Proposed
Device | Primary
Predicate | Secondary
Predicate |
| | Stainless Turbine | T1 / T2 / T3
Turbine family
with serial no. >
600,000 | Ti-Max X450 |
| | M900KL, M900W,
M900WL | T1 mini:
T1 mini S, | |
| | Pana-Max Plus:
PAP-MU M4,
PAP-SU M4 | T1 mini K,
T1 mini W,
TI mini N | |
| | Pana-Max Plus2:
PAP2-MU M4,
PAP2-SU M4 | T2 Turbines | |
| | S-Max pico:
S-Max pico,
S-Max pico KL,
S-Max pico SL, | | |
| | S-Max pico BLED,
S-Max pico WLED,
S-Max pico WHL,
S-Max pico MWL,
S-Max pico STL | T2 Control:
T2 Control S,
T2 Control K,
T2 Control W,
T2 Control N | |
| | Coupling Series | T2 Boost:
T2 Boost S,
T2 Boost K,
T2 Boost W,
T2 Boost N | |
| | LED:
PTL-CL-LED,
PTL-CL-LED III,
KCL-LED | | |
| | Glass Fiber Rod:
PTL-CL-FV-T | T2 mini:
T2 mini S,
T2 mini K,
T2 mini W,
T2 mini N | |
| | No Light Irradiation:
FM-CL-M4,
FM-CL-M4-T,
QD-J B2/B3,
QD-J M4 | | |
| | | T3 Turbines
T3 Boost:
T3 Boost S,
T3 Boost K,
T3 Boost W,
T3 Boost NQ | |
| | | T3 mini:
T3 mini S,
T3 mini K,
T3 mini W,
T3 mini NQ | |
| Power Source | Compressed Air,
Lighting powered by
Dental Unit | Compressed Air,
Lighting powered
by Dental Unit | Compressed Air,
Lighting powered
by Dental Unit |
| Device Features | Clean Head System
and Anti-Retraction
Value | Information Not
Available | Clean Head System
and Anti-Retraction
Value |
| | Proposed | Primary | Secondary |
| | Device | Predicate | Predicate |
| | Stainless Turbine | T1 / T2 / T3
Turbine family
with serial no. >
600,000 | Ti-Max X450 |
| Coupling
Dimensions or
Type | Direct Connection to
4-hole types.
(ISO 9168)
Connection via swivel
adapter to 5-, 4-, 3-,
and
2-hole types.
(ISO 9168) *1 | Connection to 4-
and 6-hole types.
(ISO 9168) | Direct Connection
to 4- and 5-hole
types. (ISO 9168)
Connection via
swivel adapter to 4-,
3-, and 2-hole types.
(ISO 9168) |
| Accessories | Handpiece Series
Spray Nozzle:
Excluding
PAP-MU M4,
PAP-SU M4,
PAP2-MU M4,
PAP2-SU M4
Cleaning Wire:
All handpiece models
Head Cap Wrench:
All handpiece models
Coupling Series
KCL Coupling Wrench:
KCL-LED
PTL Coupling Wrench:
PTL-CL-LED,
PTL-CL-LED III,
PTL-CL-FV-T,
FM-CL-M4,
FM-CL-M4-T | Sirona connection
spray adapter
KaVo connection
spray adapter
W&H connection
spray adapter
NSK MachLite
connection spray
adapter
NSK QD-J
connection spray
adapter
Morita connection
spray adapter
Yoshida
connection spray
adapter
Black nozzle
adapter
Spray water
cartridge
T1 Spray
Chuck tester | Spray Nozzle:
Excluding
X450M4, X450 5H
Cleaning Wire:
All handpiece
models
PTL O-ring Set:
Included in the
package
X450L, X450 |
| Rotation Speed | 325,000 - 450,000
min-1 | 250,000 - 400,000
min-1 | 380,000 – 450,000
min-1 |
| | Proposed
Device | Primary
Predicate | Secondary
Predicate |
| | Stainless Turbine | T1 / T2 / T3
Turbine family
with serial no. >
600,000 | Ti-Max X450 |
| Torque | $\geq$ 0.05 N·cm | Information Not
Available | $\geq$ 0.09 N·cm |
| Noise-Level | $\leq$ 80 dBA | Information Not
Available | $\leq$ 80 dBA |
| Supply Air
Pressure | 0.18 - 0.30 MPa | Information Not
Available | 0.22 - 0.30 MPa |
| Supply Water
Pressure | 0.08 - 0.20 MPa | Information Not
Available | 0.05 - 0.20 MPa |
Table 1: Comparison of the Proposed Device to the Predicate Devices
Page 4 of 11 NAKANISHI INC.
7
Page 5 of 11 NAKANISHI INC.
8
510(k) SUMMARY
9
510(k) SUMMARY
*1 Swivel adapter is the same as coupling.
10
K203791
| Proposed Device | Reference Device | Reference Device | |
|---|---|---|---|
| Stainless Turbine | Mach-Sigma | ||
| Handpiece, | |||
| Ultrapush | Mach-Sigma | ||
| Handpiece, | |||
| Ultrapush, Models | |||
| Mach-Sigma MU | |||
| (Minihead), Mach- | |||
| Sigma SU (Std. | |||
| Head), Mach-Sigma | |||
| TU (Torque Head) | |||
| 510(k) | |||
| Submitter | |||
| [Number] | NAKANISHI INC. | ||
| [K203791] | NAKANISHI INC. | ||
| [K980162] | NAKANISHI INC. | ||
| [K991701] | |||
| Indications for | |||
| Use | The Stainless | ||
| Turbine is intended | |||
| for the following | |||
| applications: Caries | |||
| removal, Cavity and | |||
| crown preparation, | |||
| Removal of dental | |||
| restorations (fillings | |||
| and prostheses), | |||
| Finishing of teeth | |||
| and dental | |||
| restorations | |||
| (preparation / | |||
| adjustment). | |||
| The Coupling is | |||
| intended for the | |||
| following | |||
| applications: A | |||
| connection device to | |||
| transfer energy (air, | |||
| water, light) | |||
| required for | |||
| handpieces. | The device is | ||
| intended for use in | |||
| general dental | |||
| applications, where | |||
| high speed cutting is | |||
| required, such as | |||
| cutting a tooth for | |||
| crown preparation, | |||
| cavity preparation, | |||
| removing metal | |||
| crown or fillings. | |||
| This device uses a | |||
| USA-patented, long | |||
| proven check valve, | |||
| a Non-Retraction | |||
| Valve, in the water | |||
| line of the handpiece | |||
| to prevent the oral | |||
| fluids, which could | |||
| be contaminated, | |||
| from being drawn | |||
| into the handpiece | |||
| spray port(s) of the | |||
| handpiece. The | |||
| contaminants could | |||
| reach beyond the | |||
| handpiece, but this | |||
| check valve, as | |||
| being installed in the | |||
| handpiece body, | |||
| prevents them from | |||
| reaching beyond the | |||
| handpiece. | The device is | ||
| intended for use in | |||
| general dental | |||
| applications, where | |||
| high speed cutting is | |||
| required, such as | |||
| cutting a tooth for | |||
| crown preparation, | |||
| cavity preparation, | |||
| removing metal | |||
| crown or fillings. | |||
| In addition to the | |||
| above Indications | |||
| for Use, we would | |||
| like to emphasize, as | |||
| a USA-patented, | |||
| long proven dust | |||
| shield mechanism, | |||
| Clean-Head System, | |||
| is used as an integral | |||
| part of the turbine | |||
| cartridge, that this | |||
| device is able to | |||
| substantially reduce | |||
| bacterial | |||
| contamination of the | |||
| handpiece exhaust | |||
| air lines to the dental | |||
| unit. | |||
| Proposed Device | Reference Device | Reference Device | |
| Stainless Turbine | Mach-Sigma | ||
| Handpiece, | |||
| Ultrapush | Mach-Sigma | ||
| Handpiece, | |||
| Ultrapush, Models | |||
| Mach-Sigma MU | |||
| (Minihead), Mach- | |||
| Sigma SU (Std. | |||
| Head), Mach-Sigma | |||
| TU (Torque Head) | |||
| Device Models | Handpiece Series | ||
| S-Max M: | |||
| M500, M500L, | |||
| M500K, M500KL, | |||
| M500SL, M600, | |||
| M600L, M600K, | |||
| M600KL, M600SL, | |||
| M600WLED, | |||
| M800, M800L, | |||
| M800KL, | |||
| M800WL, M900, | |||
| M900L, M900K, | |||
| M900KL, M900W, | |||
| M900WL | |||
| Pana-Max Plus: | |||
| PAP-MU M4, | |||
| PAP-SU M4 | |||
| Pana-Max Plus2: | |||
| PAP2-MU M4, | |||
| PAP2-SU M4 | |||
| S-Max pico: | |||
| S-Max pico, | |||
| S-Max pico KL, | |||
| S-Max pico SL, | |||
| S-Max pico BLED, | |||
| S-Max pico WLED, | |||
| S-Max pico WHL, | |||
| S-Max pico MWL, | |||
| S-Max pico STL | |||
| Coupling Series | |||
| LED: | |||
| PTL-CL-LED, | |||
| PTL-CL-LED III, | |||
| KCL-LED | |||
| Glass Fiber Rod: | |||
| PTL-CL-FV-T | Mach-Sigma MU | ||
| (Mini), | |||
| Mach-Sigma SU | |||
| (Standard), | |||
| Mach-Sigma TU | |||
| (Torque) | Mach-Sigma MU | ||
| (Mini Head), | |||
| Mach-Sigma SU | |||
| (Standard Head), | |||
| Mach-Sigma TU | |||
| (Torque Head | |||
| Proposed Device | Reference Device | Reference Device | |
| Stainless Turbine | Mach-Sigma | ||
| Handpiece, | |||
| Ultrapush | Mach-Sigma | ||
| Handpiece, | |||
| Ultrapush, Models | |||
| Mach-Sigma MU | |||
| (Minihead), Mach- | |||
| Sigma SU (Std. | |||
| Head), Mach-Sigma | |||
| TU (Torque Head) | |||
| No Light Irradiation: | |||
| FM-CL-M4, | |||
| FM-CL-M4-T, | |||
| QD-J B2/B3, | |||
| QD-J M4 | |||
| Power Source | Compressed Air, | ||
| Lighting powered by | |||
| Dental Unit | Compressed Air | Compressed Air | |
| Coupling | |||
| Dimensions or | |||
| Type | Direct Connection to | ||
| 4-hole types. | |||
| (ISO 9168) | |||
| Connection via | |||
| swivel adapter to 5-, | |||
| 4-, 3-, and 2-hole | |||
| types. (ISO 9168) *1 | Direct Connection to | ||
| 4-hole types. | |||
| (ISO 9168) | Direct Connection to | ||
| 4-hole types. | |||
| (ISO 9168) | |||
| Device Features | Clean Head System | ||
| and Anti-Retraction | |||
| Valve | Anti-Retraction | ||
| Valve | Clean Head System | ||
| and Anti-Retraction | |||
| Valve | |||
| Rotation Speed | 325,000 – 450,000 | ||
| min-1 | Standard: | ||
| 400,000 min-1 | |||
| Mini: 400,000 min-1 | |||
| Torque: | |||
| 320,000 min-1 | Standard: | ||
| 400,000 min-1 | |||
| Mini: 400,000 min-1 | |||
| Torque: | |||
| 320,000 min-1 | |||
| Torque | ≥ 5.0 g·cm | Standard: 8.0 g·cm | |
| Mini: 7.5 g·cm | |||
| Torque: 13 g·cm | Standard: 8.0 g·cm | ||
| Mini: 7.5 g·cm | |||
| Torque: 13 g·cm | |||
| Noise-Level | ≤ 80 dBA | 75 dBA max. at | |
| 2 kg/cm² air | 75 dBA max. at | ||
| 2 kg/cm² air | |||
| Supply Air | |||
| Pressure | 0.18 – 0.30 MPa | ||
| (1.8 - 3.0 kg/cm²) | 1.8 - 2.0 kg/cm² | 1.8 - 2.0 kg/cm² | |
| Supply Water | |||
| Pressure | 0.08 – 0.20 MPa | ||
| (0.8 - 2.0 kg/cm²) | ≤ 2.0 kg/cm² | ≤ 2.0 kg/cm² |
Table 2: Comparison of the Proposed Device to the Reference Devices
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Page 9 of 11 NAKANISHI INC.
12
*1 Swivel adapter is the same as coupling.
13
NSK
K203791
In summary, the following minor differences exist between the subject device and the predicate and reference devices:
- Intended Use:
- An additional accessory has been included in the Indications for Use for the O subject device
- Technological characteristics: ●
- O Dimensions and weight
- Number and functions of compatible accessories O
- Compatible coupling/connection types (all types are ISO 9168 standard O compliant)
These differences do not raise different questions of safety and effectiveness.
The Stainless Turbine handpieces and couplings were developed and are produced under Summary of Performance the consideration of all applicable technical standards, internal specifications, and FDA Testing: guidance documents. The devices' conformance with applicable international and internal standards was verified over the course of bench testing. Tests were performed on the handpieces including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent to FDA cleared devices. Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of Health Care Products – Moist Heat - Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. Documentation was provided demonstrating that the Stainless Turbine handpieces and couplings comply with the requirements stated in the FDA guidance document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff. Biocompatibility evaluations were selected in accordance with ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing and the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and Testing. In addition. testing for performance of the handpieces was conducted in accordance with ISO 14457:2012 Dentistry - Handpieces and motors.
- Conclusion: NAKANISHI INC. considers the Stainless Turbine handpieces to be substantially equivalent to the predicate devices referenced above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.