(540 days)
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 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.
The provided text describes a 510(k) premarket notification for a dental handpiece and its accessories, referred to as the "Stainless Turbine." The submission aims to demonstrate that this new device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as separate targets but are implied through the comparison with predicate devices and claims of conformance to ISO standards. The performance characteristics of the proposed Stainless Turbine and the predicate/reference devices are presented in Tables 1 and 2 of the document.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Reference) | Reported Device Performance (Stainless Turbine) |
|---|---|---|
| Rotation Speed | Primary Predicate: 250,000 - 400,000 min-1 Secondary Predicate: 380,000 – 450,000 min-1 | 325,000 - 450,000 min-1 |
| Torque | Primary Predicate: Information Not Available Secondary Predicate: $\geq$ 0.09 N·cm Reference (Mach-Sigma): Standard: 8.0 g·cm, Mini: 7.5 g·cm, Torque: 13 g·cm (Note: g·cm needs conversion to N·cm for direct comparison with Secondary Predicate; 1 g·cm = 0.000980665 N·cm. So, 8.0 g·cm = 0.0078 N·cm, 7.5 g·cm = 0.0074 N·cm, 13 g·cm = 0.0127 N·cm) | $\geq$ 0.05 N·cm or $\geq$ 5.0 g·cm (Presented in both units, with a note in g·cm in Table 2) |
| Noise-Level | Primary Predicate: Information Not Available Secondary Predicate: $\leq$ 80 dBA Reference (Mach-Sigma): 75 dBA max. at 2 kg/cm² air | $\leq$ 80 dBA |
| Supply Air Pressure | Primary Predicate: Information Not Available Secondary Predicate: 0.22 - 0.30 MPa Reference (Mach-Sigma): 1.8 - 2.0 kg/cm² (0.176 - 0.196 MPa) | 0.18 - 0.30 MPa (1.8 - 3.0 kg/cm²) |
| Supply Water Pressure | Primary Predicate: Information Not Available Secondary Predicate: 0.05 - 0.20 MPa Reference (Mach-Sigma): $\leq$ 2.0 kg/cm² ($\leq$ 0.196 MPa) | 0.08 - 0.20 MPa (0.8 - 2.0 kg/cm²) |
| Bur Conformity | Predicate/Reference devices are intended for use with friction grip bur conforming to ISO 1797-1 standard. | Intended for use with a friction grip bur that conforms to ISO 1797-1 standard. |
| Connection Types | Predicate/Reference: Various ISO 9168 compliant connections. | Direct Connection to 4-hole types. (ISO 9168); Connection via swivel adapter to 5-, 4-, 3-, and 2-hole types. (ISO 9168) |
| Special Features | Secondary Predicate: Clean Head System and Anti-Retraction Value. Reference (K980162): Anti-Retraction Valve. Reference (K991701): Clean Head System and Anti-Retraction Valve. | Clean Head System and Anti-Retraction Value |
2. Sample size used for the test set and the data provenance
The document states: "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." However, it does not provide any specific sample sizes for the test set or details about the data provenance (e.g., country of origin, retrospective or prospective). It simply refers to "bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing appears to be functional and engineering-based (bench testing) rather than involving human experts for ground truth establishment.
4. Adjudication method for the test set
This information is not provided in the document, as the testing described is primarily technical and quantitative, not involving clinical adjudication.
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
This information is not applicable to this device. The Stainless Turbine is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool for human readers/clinicians. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this device, as it is a mechanical dental tool and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the technical performance characteristics (rotation speed, torque, noise level, pressure), the "ground truth" or reference for comparison appears to be the specifications and performance of legally marketed predicate and reference devices, as well as conformance to international standards (e.g., ISO 1797-1, ISO 9168, ISO 14457:2012). For sterilization, the ground truth is conformance to ISO 17665-1:2006. For biocompatibility, it's ISO 10993-1:2018 and FDA guidance. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for verification of this type of device.
8. The sample size for the training set
This information is not applicable to this device, as it is a mechanical device and not an algorithm or AI system that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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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
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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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| 510(k) SUMMARY | K203791 | |
|---|---|---|
| Submitter: | NAKANISHI INC.700 ShimohinataKanuma Tochigi 322-8666 Japan | |
| Contact Person: | Mr. Masaaki KikuchiGeneral Manager, Regulatory Affairs Dept.TEL: +81-289-64-7277FAX: +81-289-62-9738m-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: | K203791NAKANISHI INC.Stainless TurbineHandpiece, Air-Powered, DentalClass IDental handpiece and accessoriesEFB872.4200 |
| PrimaryPredicate Device: | Clearance:Manufacturer:Trade Name:Common Name:Regulatory Class:Classification Name:Product Code:Regulation: | K131319Sirona Dental Systems GmbHT1 / T2 / T3 Turbine family with serial no. > 600,000Handpiece, Air-Powered, DentalClass IDental handpiece and accessoriesEFB872.4200 |
| SecondaryPredicate Device: | Clearance:Manufacturer:Trade Name:Common Name:Regulatory Class:Classification Name:Product Code:Regulation: | K112024NAKANISHI INC.Ti-Max X450Handpiece, Air-Powered, DentalClass IDental handpiece and accessoriesEFB872.4200 |
| 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-SigmaMU (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 | |
| DeviceDescription: | The Stainless Turbine handpieces are air driven dental handpieces for use by a trainedprofessional in the field of general dentistry. The handpieces are air-powered, high-speed dental handpieces capable of reaching rotational speeds of 325,000 to 450,000revolutions per minute. Handpiece models include fiber optic, LED, and non-opticlighting. 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. TheStainless Turbine couplings are connection devices used to attach the dental unit tothe Stainless Turbine handpieces. Available coupling models include the Glass FiberRod Series, LED Series, and No Light Irradiation Series. | |
| Indications forUse: | The Stainless Turbine is intended for the following applications: Caries removal,Cavity and crown preparation, Removal of dental restorations (fillings andprostheses), Finishing of teeth and dental restorations (preparation/adjustment).The coupling is intended for the following applications: A connection device totransfer energy (air, water, light) required for handpieces. |
Page 1 of 11 NAKANISHI INC.
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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
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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.
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K203791
| ProposedDevice | PrimaryPredicate | SecondaryPredicate | |
|---|---|---|---|
| Stainless Turbine | T1 / T2 / T3Turbine familywith serial no. >600,000 | Ti-Max X450 | |
| 510(k)Submitter[Number] | NAKANISHI INC.[K203791] | Sirona DentalSystems GmbH[K131319] | NAKANISHI INC.[K112024] |
| Indications forUse | The Stainless Turbineis intended for thefollowing applications:Caries removal, Cavityand crown preparation,Removal of dentalrestorations (fillingsand prostheses),Finishing of teeth anddental restorations(preparation /adjustment).The Coupling isintended for thefollowing applications:A connection device totransfer energy (air,water, light) requiredfor handpieces. | The turbines of theT1 / T2 / T3Turbine family areintended for thePreparation ofcavities andcrowns, Removalof cariousmaterial, Removalof fillings,Processing oftooth andrestorationsurfaces, Reducinghard toothstructure. | The Ti-Max X450 isan air-powereddental handpiecewith intended use ofbeing a surgical toolfor impacted thirdmolar removal andperiodontalprocedures forwhich aconventionalhandpiece would beused. The Ti-MaxX450 is intended foruse with a frictiongrip bur thatconforms to ISO1797-1 standard.Recommendedsupply air pressureis between 0.22 and0.30 MPa, whichresults in high speedbur rotation(approximately380,000 to 450,000RPM). |
| Model Numbers | Handpiece SeriesS-Max M:M500, M500L,M500K, M500KL,M500SL, M600,M600L, M600K,M600KL, M600SL,M600WLED, M800,M800L, M800KL,M800WL, M900,M900L, M900K, | T1 TurbinesT1 Control:T1 Control S,T1 Control K,T1 Control W,T1 Control NT1 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 |
| ProposedDevice | PrimaryPredicate | SecondaryPredicate | |
| Stainless Turbine | T1 / T2 / T3Turbine familywith 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 TurbinesT3 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 byDental Unit | Compressed Air,Lighting poweredby Dental Unit | Compressed Air,Lighting poweredby Dental Unit |
| Device Features | Clean Head Systemand Anti-RetractionValue | Information NotAvailable | Clean Head Systemand Anti-RetractionValue |
| Proposed | Primary | Secondary | |
| Device | Predicate | Predicate | |
| Stainless Turbine | T1 / T2 / T3Turbine familywith serial no. >600,000 | Ti-Max X450 | |
| CouplingDimensions orType | Direct Connection to4-hole types.(ISO 9168)Connection via swiveladapter to 5-, 4-, 3-,and2-hole types.(ISO 9168) *1 | Connection to 4-and 6-hole types.(ISO 9168) | Direct Connectionto 4- and 5-holetypes. (ISO 9168)Connection viaswivel adapter to 4-,3-, and 2-hole types.(ISO 9168) |
| Accessories | Handpiece SeriesSpray Nozzle:ExcludingPAP-MU M4,PAP-SU M4,PAP2-MU M4,PAP2-SU M4Cleaning Wire:All handpiece modelsHead Cap Wrench:All handpiece modelsCoupling SeriesKCL Coupling Wrench:KCL-LEDPTL Coupling Wrench:PTL-CL-LED,PTL-CL-LED III,PTL-CL-FV-T,FM-CL-M4,FM-CL-M4-T | Sirona connectionspray adapterKaVo connectionspray adapterW&H connectionspray adapterNSK MachLiteconnection sprayadapterNSK QD-Jconnection sprayadapterMorita connectionspray adapterYoshidaconnection sprayadapterBlack nozzleadapterSpray watercartridgeT1 SprayChuck tester | Spray Nozzle:ExcludingX450M4, X450 5HCleaning Wire:All handpiecemodelsPTL O-ring Set:Included in thepackageX450L, X450 |
| Rotation Speed | 325,000 - 450,000min-1 | 250,000 - 400,000min-1 | 380,000 – 450,000min-1 |
| ProposedDevice | PrimaryPredicate | SecondaryPredicate | |
| Stainless Turbine | T1 / T2 / T3Turbine familywith serial no. >600,000 | Ti-Max X450 | |
| Torque | $\geq$ 0.05 N·cm | Information NotAvailable | $\geq$ 0.09 N·cm |
| Noise-Level | $\leq$ 80 dBA | Information NotAvailable | $\leq$ 80 dBA |
| Supply AirPressure | 0.18 - 0.30 MPa | Information NotAvailable | 0.22 - 0.30 MPa |
| Supply WaterPressure | 0.08 - 0.20 MPa | Information NotAvailable | 0.05 - 0.20 MPa |
Table 1: Comparison of the Proposed Device to the Predicate Devices
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510(k) SUMMARY
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510(k) SUMMARY
*1 Swivel adapter is the same as coupling.
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K203791
| Proposed Device | Reference Device | Reference Device | |
|---|---|---|---|
| Stainless Turbine | Mach-SigmaHandpiece,Ultrapush | Mach-SigmaHandpiece,Ultrapush, ModelsMach-Sigma MU(Minihead), Mach-Sigma SU (Std.Head), Mach-SigmaTU (Torque Head) | |
| 510(k)Submitter[Number] | NAKANISHI INC.[K203791] | NAKANISHI INC.[K980162] | NAKANISHI INC.[K991701] |
| Indications forUse | The StainlessTurbine is intendedfor the followingapplications: Cariesremoval, Cavity andcrown preparation,Removal of dentalrestorations (fillingsand prostheses),Finishing of teethand dentalrestorations(preparation /adjustment).The Coupling isintended for thefollowingapplications: Aconnection device totransfer energy (air,water, light)required forhandpieces. | The device isintended for use ingeneral dentalapplications, wherehigh speed cutting isrequired, such ascutting a tooth forcrown preparation,cavity preparation,removing metalcrown or fillings.This device uses aUSA-patented, longproven check valve,a Non-RetractionValve, in the waterline of the handpieceto prevent the oralfluids, which couldbe contaminated,from being drawninto the handpiecespray port(s) of thehandpiece. Thecontaminants couldreach beyond thehandpiece, but thischeck valve, asbeing installed in thehandpiece body,prevents them fromreaching beyond thehandpiece. | The device isintended for use ingeneral dentalapplications, wherehigh speed cutting isrequired, such ascutting a tooth forcrown preparation,cavity preparation,removing metalcrown or fillings.In addition to theabove Indicationsfor Use, we wouldlike to emphasize, asa USA-patented,long proven dustshield mechanism,Clean-Head System,is used as an integralpart of the turbinecartridge, that thisdevice is able tosubstantially reducebacterialcontamination of thehandpiece exhaustair lines to the dentalunit. |
| Proposed Device | Reference Device | Reference Device | |
| Stainless Turbine | Mach-SigmaHandpiece,Ultrapush | Mach-SigmaHandpiece,Ultrapush, ModelsMach-Sigma MU(Minihead), Mach-Sigma SU (Std.Head), Mach-SigmaTU (Torque Head) | |
| Device Models | Handpiece SeriesS-Max M:M500, M500L,M500K, M500KL,M500SL, M600,M600L, M600K,M600KL, M600SL,M600WLED,M800, M800L,M800KL,M800WL, M900,M900L, M900K,M900KL, M900W,M900WLPana-Max Plus:PAP-MU M4,PAP-SU M4Pana-Max Plus2:PAP2-MU M4,PAP2-SU M4S-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 STLCoupling SeriesLED:PTL-CL-LED,PTL-CL-LED III,KCL-LEDGlass 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-SigmaHandpiece,Ultrapush | Mach-SigmaHandpiece,Ultrapush, ModelsMach-Sigma MU(Minihead), Mach-Sigma SU (Std.Head), Mach-SigmaTU (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 byDental Unit | Compressed Air | Compressed Air |
| CouplingDimensions orType | Direct Connection to4-hole types.(ISO 9168)Connection viaswivel adapter to 5-,4-, 3-, and 2-holetypes. (ISO 9168) *1 | Direct Connection to4-hole types.(ISO 9168) | Direct Connection to4-hole types.(ISO 9168) |
| Device Features | Clean Head Systemand Anti-RetractionValve | Anti-RetractionValve | Clean Head Systemand Anti-RetractionValve |
| Rotation Speed | 325,000 – 450,000min-1 | Standard:400,000 min-1Mini: 400,000 min-1Torque:320,000 min-1 | Standard:400,000 min-1Mini: 400,000 min-1Torque:320,000 min-1 |
| Torque | ≥ 5.0 g·cm | Standard: 8.0 g·cmMini: 7.5 g·cmTorque: 13 g·cm | Standard: 8.0 g·cmMini: 7.5 g·cmTorque: 13 g·cm |
| Noise-Level | ≤ 80 dBA | 75 dBA max. at2 kg/cm² air | 75 dBA max. at2 kg/cm² air |
| Supply AirPressure | 0.18 – 0.30 MPa(1.8 - 3.0 kg/cm²) | 1.8 - 2.0 kg/cm² | 1.8 - 2.0 kg/cm² |
| Supply WaterPressure | 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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*1 Swivel adapter is the same as coupling.
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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.
§ 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.