(207 days)
Not Found
No
The description focuses on mechanical and air-driven mechanisms for dental procedures and does not mention any AI/ML components or functionalities.
No
The device is described as a tool for dental operations like cutting and drilling, used to hold rotary instruments. While it performs procedures on the body, it is a mechanical tool for physical alteration rather than a device that provides therapy for an illness or condition.
No
The device is described as surgical instruments used for mechanical operations like cutting, drilling, and polishing, not for diagnosing conditions.
No
The device description clearly outlines a physical device with mechanical components (motor, turbine, shaft core, needles) and fluid systems (air and water circuits) for performing dental procedures. This is not a software-only device.
Based on the provided information, 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 (removing material, preparing cavities, finishing restorations, etc.). IVD devices are used to examine specimens from the body (like blood, urine, tissue) to provide information about a patient's health status.
- Device Description: The description details a mechanical device used to hold and drive rotary instruments for cutting and drilling teeth. This is a physical intervention on the patient, not an analysis of a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
This device is a dental handpiece, which is a surgical/procedural tool used in dentistry.
N/A
Intended Use / Indications for Use
High-speed Air Turbine Handpieces: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Product codes
EFB, EGS
Device Description
The proposed device is used to hold rotary instruments such as burs and drills to drive movements to achieve dental operations such as cutting, and drilling. The working principle of the proposed device is that the current and compressed air arrive at the nose through each control valve of the circuit system and air circuit system to drive the motor, turbine (or blade) rotation (shaft core rotation), thus driving the needle rotation to achieve the purpose of drilling and tooth cutting, and the other water and air meet the head to achieve the cooling purpose through each control valve.
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
Not Found
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- Pyrogen Study in Rabbits using USP General Chapter Pyrogen Test
- IEC 60601-1: 2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ISO 60601-1-2: 2020 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 80601-2-60: 2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
- ISO 14457: 2017 Dentistry - Handpieces and motors
- ISO 17664: 2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
- 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
- ISO 9168: 2009 Dentistry - Hose connectors for air driven dental handpieces
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
November 12, 2024
Foshan SOCO Precision Instrument Co.,Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, 102401 China
Re: K241074
Trade/Device Name: High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB, EGS
Dated: October 14, 2024 Received: October 15, 2024
Dear Ray Wang:
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 (the 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 available 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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical
2
devices/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,
Bobak Shirmohammadi -S
For Michael E. Adjodha, MChE, RAC, CQIA 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
3
Indications for Use
Submission Number (if known)
Device Name
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22); Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) Indications for Use (Describe) High-speed Air Turbine Handpieces: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors: It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth. 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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4
The assigned 510(k) Number:
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
- Date of Preparation: 10/14/2024 1.
-
- Sponsor Identification
Foshan SOCO Precision Instrument Co.,Ltd.
3-5 FL. Bldg 4, District A and 5 FL. Bldg 3, District A Guangdong New Light Source Industrial Base, Luocun, Shishan Town, Nanhai District, Foshan City, 52826, Guangdong, P.R. China Contact Person: Xiao Gou Position: Regulator's Representative/PRRC Tel: +86-13876245168 Fax: +86-0757-81806003 Email: 824283813@qq.com
-
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, China, 102401 Contact Person: Ray Wang Position: General Manager Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
- Designated Submission Correspondent
| Trade Name | Model |
|---|---|
| High-speed Air Turbine Handpieces | SCHG01, SCHG03, SCHG18, SCHF19, SCHF22 |
| Dental Low Speed Handpieces | |
| including Straight and Geared Angle | |
| Handpieces and Air Motors | Straight Handpieces: |
| SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S | |
| Geared Angle Handpieces: | |
| SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, | |
| SCHD24-C, SCHD27-C, SCHD29-S. |
4. Identification of Proposed Device
5
| SCHB4, SCHB5, SCHB20, SCHB64 |
|---|
| Air Motors: |
| SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M |
Common Name: Handpiece, Air-Powered, Dental
Regulatory Information
Classification Name: Handpiece, Air-Powered, Dental Classification: I Product Code: EFB; EGS Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulation Medical Specialty: Dental Review Panel: Dental
Indication For Use Statement:
High-speed Air Turbine Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
న. Device Description
The proposed device is used to hold rotary instruments such as burs and drills to drive movements to achieve dental operations such as cutting, and drilling. The working principle of the proposed device is that the current and compressed air arrive at the nose through each control valve of the circuit system and air circuit system to drive the motor, turbine (or blade) rotation (shaft core rotation), thus driving the needle rotation to achieve the purpose of drilling and tooth cutting, and the other water and air meet the head to achieve the cooling purpose through each control valve.
6. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K220179 Product Name: High-Speed Air Turbine Handpieces / Straight Handpieces / Geared Angle Handpieces / Air Motors Manufacturer: Foshan COXO Medical Instrument Co., Ltd.
6
-
Non-Clinical Test Conclusion 7.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
A ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for irritation > and skin sensitization
-
A ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
Pyrogen Study in Rabbits using USP General Chapter Pyrogen Test A
-
IEC 60601-1: 2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
ISO 60601-1-2: 2020 Medical electrical equipment Part 1-2: General requirements for A basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
IEC 80601-2-60: 2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
-
ISO 14457: 2017 Dentistry - Handpieces and motors
-
A ISO 17664: 2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
-
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
-
A ISO 9168: 2009 Dentistry - Hose connectors for air driven dental handpieces
-
Clinical Test Conclusion 8.
No clinical study is included in this submission.
- Substantially Equivalent (SE) Comparison 9.
Table 1 General Comparison
| Item | Proposed Device (K241074) | Predicate Device (K220179) | Remark |
|---|---|---|---|
| Manufacturer | Foshan SOCO Precision Instrument Co.,Ltd. | Foshan COXO Medical Instrument Co., Ltd. | / |
| Device Name | High-speed Air Turbine Handpieces / Dental Low | ||
| Speed Handpieces including Straight and Geared | |||
| Angle Handpieces and Air Motors | High-Speed Air Turbine Handpieces/ Straight | ||
| Handpieces/ Geared Angle Handpieces/ Air Motors | / |
7
| Model | High-speed Air Turbine Handpieces:
SCHG01, SCHG03, SCHG18, SCHF19, SCHF22
Dental Low Speed Handpieces including Straight
and Geared Angle Handpieces and Air Motors:
Straight Handpieces:
SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S,
SCHD27-S
Geared Angle Handpieces:
SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C,
SCHD24-C, SCHD27-C, SCHD29-S,
SCHB4, SCHB5, SCHB20, SCHB64
Air Motors:
SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M | High-Speed Air Turbine Handpieces:
CX207, CX207-G, CX207-2, CX207-A, CX207-A-2,
CX207-B, CX207-B-2, CX207-C, CX207-C-2,
CX207-W, CX207-W-2
Straight Handpieces:
CX235-2, CX235-2A, CX235-2B, CX235-2F,
CX235-2G, CX235-2C, CX235-2S2
Geared Angle Handpieces:
CX235-1B, CX235-1C, CX235-1F, CX235-1G,
CX235C1, CX235C2, CX235C3, CX235C4,
CX235C5, CX235C6, CX235C7, CX235C8,
CX235-2S, CX235-2S1
Air Motors:
CX235-3B, CX235-3F, CX235-3C | Analysis 1 | | Proposed | Predicate | Proposed | Predicate | Proposed | Predicate | Proposed | Predicate | Proposed | Predicate | |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-------------------|-----------------------------------|--------------------------|-------------|-------------|-----------------------------------|-------------|-------------|-------------|-------------|-------------|------------|
| Product Code | EFB, EGS | EFB, EGS | SAME | | Device | Device | Device | Device | Device | Device | Device | Device | Device | Device | |
| Regulation No. | 21 CFR 872.4200 | 21 CFR 872.4200 | SAME | Item | (K241074) | (K220179) | (K241074) | (K220179) | (K241074) | (K220179) | (K241074) | (K220179) | (K241074) | (K220179) | Remark |
| Class | I | I | SAME | | Model: | Model: | Model: | Model: | Model: | Model: | Model: | Model: | Model: | Model: | |
| Indication
For Use | High-speed Air Turbine Handpieces:
It is intended for removing carious material, excess
filling material, cavity and crown preparation,
finishing tooth preparations and restorations, root
canal preparations and polishing teeth.
Dental Low Speed Handpieces including Straight
and Geared Angle Handpieces and Air Motors:
It is intended for removing carious material, excess
filling material, cavity and crown preparation,
finishing tooth preparations and restorations, root
canal preparations and polishing teeth. | High-Speed Air Turbine Handpieces:
It is intended for removing carious material, excess
filling material, cavity and crown preparation,
finishing tooth preparations and restorations, root
canal preparations and polishing teeth.
Straight Handpieces:
It is intended for removing carious material, excess
filling material, cavity and crown preparation,
finishing tooth preparations and restorations, root
canal preparations and polishing teeth.
Geared Angle Handpieces:
It is intended for removing carious material, excess
filling material, cavity and crown preparation,
finishing tooth preparations and restorations, root
canal preparations and polishing teeth.
Air Motors:
It is intended for removing carious material, excess
filling material, cavity and crown preparation,
finishing tooth preparations and restorations, root
canal preparations and polishing teeth. | SAME | | SCHG01 | CX207 | SCHG03 | CX207-W | SCHG18 | CX207-A | SCHF19 | CX207-G | SCHF22 | CX207-W | |
| Air/water ports | 4/6 ports | 2/4/6 ports | SAME | Angle | 20° | 20° | 20° | 20° | 20° | 20° | 20° | 20° | 45° | 20° | Analysis 3 |
| Fiber optic Glass
Rod | SCHB5, SCHD24-S, SCHD24-C | CX207-G, CX235-1C, CX235C7 | Analysis 1 | Cartridge | Collet/Open | Collet/Open | Open | Open | Open | Open | Open | Open | Collet/Open | Open | SAME |
| Composition of
material | Copper (chromium plating), aluminum,
rubber and stainless steel | Copper (chromium plating), aluminum,
rubber and stainless steel | SAME | Operational modes | Air-powered | Air-powered | Air-powered | Air-powered | Air-powered | Air-powered | Air-powered | Air-powered | Air-powered | Air-powered | SAME |
| Chuck | Push button, Latch, Wrench | Push button, Screw | Analysis 2 | Chuck Type | Push button | Push button | Push button | Push button | Push button | Push button | Push button | Push button | Push button | Push button | SAME |
| | | | | Spray | 1 way spray | 1 way spray | 3 way spray | 3 way spray | 1 way spray | 1 way spray | 3 way spray | 3 way spray | 3way spray | 3 way spray | SAME |
| Maximum air
pressure | High-speed Air Turbine Handpieces: 0.2 ~0.25Mpa
Dental Low Speed Handpieces including Straight and
Geared Angle Handpieces and Air Motors: 0.245MPa
~ 0.3925MPa | High-speed Air Turbine Handpieces: 0.2 ~0.25Mpa
Straight handpiece & Geared Angle handpiece & Air
Motors: 0.245MPa ~ 0.3925MPa | SAME | Hole | 4 hole | 4 hole | 4 hole | 4 hole | 4 hole | 4 hole | 6 hole | 6 hole | 4 hole | 4 hole | SAME |
| Maximum water
pressure | High-speed Air Turbine Handpieces: 0.2 ~0.25Mpa
Dental Low Speed Handpieces including Straight and
Geared Angle Handpieces and Air Motors: 0.245MPa
~ 0.3925MPa | High-Speed Air Turbine Handpieces: 0.2 ~0.25Mpa
Straight handpiece & Geared Angle handpiece & Air
Motors: 0.245MPa ~ 0.3925MPa | SAME | LED | / | / | / | / | / | / | LED | LED | LED | / | Analysis 3 |
| Speed in rpms | High-speed Air Turbine Handpieces:
280000 ~ 450000rpm
Dental Low Speed Handpieces including Straight and
Geared Angle Handpieces and Air Motors:
7000 lux | >7000 lux | >7000 lux | / | Analysis 3 |
| Coupling
dimensions | Complied with ISO 3964 | Complied with ISO 3964 | SAME | Fiber | / | / | / | / | / | / | / | / | / | / | SAME |
| Hose connections | Type 2 for 4- hole model
Type 3 for 6-hole model | Type 1 for 2-hole model / Type 2 for 4- hole
Model / Type 3 for 6-hole model | SAME | | Proposed Device (K241074) | | | | Predicate Device (K220179) | | | | | Remark | |
| Lubricant | The lubricants approved by FDA, such as DO-ALL
Dental Handpiece Lubricant (K073353) | The lubricants approved by FDA, such as DO-ALL
Dental Handpiece Lubricant (K073353) | SAME | | High-speed Air Turbine Handpieces | | | | High-Speed Air Turbine Handpieces | | | | | | |
| Compliance
Standards | Complied with ISO 10993- 5, ISO 10993-10, ISO
10993-11, USP Pyrogen Testing, IEC 60601-1,
IEC 60601-1-2, IEC 80601- 2-60, ISO 14457, ISO
17664, ISO 17665-1, ISO 9168 | Complied with ISO 10993- 5, ISO 10993-10, ISO
10993-23, ISO 10993-11, USP Pyrogen
Testing, IEC 60601-1, IEC 60601-1-2, IEC 80601-
2-60, ISO 14457, ISO 17664, ISO 17665-1, ISO 9168 | SAME | Grip | Complied with ISO 1797-1 | | | | Complied with ISO 1797-1 | | | | SAME | | |
| Size | | Complied with ISO 1797-1 | | | | Complied with ISO 1797-1 | | | | SAME | | | | | |
8
Analysis 1
The comparison between the proposed device and each model of the predicate device is shown in Tables 2- Table 5.
Analysis 2
The proposed device is different in Chuck from the predicate device. However, the different not affect the safety and effectiveness of proposed device. Based on the nonclinical tests performed, the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device.
9
Table 2 Technical comparison for High-speed Air Turbine Handpieces
10
| Rotation Speed | 280000 ~ 450000rpm | 280,000 rpm ~ 450,000 rpm | SAME |
|---|---|---|---|
| Coolant Air Supply | > 1.5L/min (at 200kPa) | >1.5 L/min (at 200kPa) | SAME |
| Coolant Water Supply | >50 mL/min (at 200kPa) | >50 mL/min (at 200kPa) | SAME |
| Rated Torque | >0.0005N .m | >0.0005N.m (6 hole and 4 hole at 0.28 MPa, 2 hole at 0.22 MPa) | SAME |
| Air Pressure | 0.2~0.25Mpa | 0.2 MPa ~ 0.25MPa | SAME |
| Water Pressure | 0.2 MPa~0.25MPa | 0.2 MPa ~ 0.25MPa | SAME |
| Bur extraction force | 22N | 22N | SAME |
| Bur type | Shaft diameter: 1.59 to 1.60 mm, Overall length: max. 23 mm, Shaft clamping | ||
| length: at least 11 mm, Blade diameter: max.2 mm | ISO 1797-1 Type 3, diameter: 1.6mm, fitting length: min. 11mm, overall length: max. | ||
| 23mm, working diameter: max. 2mm. | SAME | ||
| Flow rate | 7000Lux | >7000Lux | / |
| Water cooling (ml/min) | / | / | / |
| Air cooling (L/min) | / | / | / |
| / | |||
| Item | Proposed Device (K241074) | ||
| Straight Handpieces | |||
| Straight Handpieces | |||
| Coulping dimensions | Comply with ISO 3964 | ||
| Bur extraction force | >32 N | ||
| Bur type | ISO 1797, type 1, diameter 2.35mm, shaft cmalping length: Minimal 11mm, overall | ||
| length: max 23mm, blade diameter: max 2mm | |||
| ISO 1797, type 2, diameter 2.35mm, shaft cmalping length: Minimal 33mm, overall | |||
| length: max 50mm, blade diameter: max 2mm. | |||
| working diameter: max.2mm. | |||
| ISO 1797-1 Type 2, diameter: 2.35mm, fiting length: min.33mm, overall length: | |||
| max.50mm, working diameter: max.2mm. |
Table 4-1 Technical comparison for Geared Angle Handpieces
| | Proposed
Device
(K241074) | | Predicate
Device
(K220179) | | Proposed
Device
(K241074) | | Predicate
Device
(K220179) | | Proposed
Device
(K241074) | | Predicate
Device
(K220179) | | |
|------|---------------------------------|--|----------------------------------|--|---------------------------------|--|----------------------------------|--|---------------------------------|--|----------------------------------|--|--------|
| Item | | | | | | | | | | | | | Remark |
12
| | Model:
SCHD05-C | Model:
CX235C1 | Model:
SCHD06-C | Model:
CX235C2 | Model:
SCHD16-C | Model:
CX235-1F | Model:
SCHD17-C | Model:
CX235-1B | Model:
SCHD24-C | Model:
CX235-1C | Model:
SCHD27-C | Model:
CX235-1G | |
|---------------------------|--------------------|-------------------|--------------------|-------------------|--------------------|--------------------|--------------------|--------------------|--------------------|--------------------|--------------------|--------------------|------------|
| Angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | SAME |
| Transmission
Ratio | 1:1 | 1:1 | 1:1 | 1:1 | 1:1 | 1:1 | 1:1 | 1:1 | 1:1 | 1:1 | 1:1 | 1:1 | SAME |
| Speed (rpm) | 50
(200kPa) | > 50
(200kPa) | > 50
(200kPa) | > 50
(200kPa) | > 50
(200kPa) | > 50
(200kPa) | SAME |
| Air cooling
(L/min) | / | / | / | / | / | / | > 1.5
(200kPa) | > 1.5
(200kPa) | > 1.5
(200kPa) | > 1.5
(200kPa) | > 1.5
(200kPa) | > 1.5
(200kPa) | SAME |
| LED | / | / | / | / | / | / | / | / | / | / | / | / | SAME |
| Fiber | / | / | / | / | / | / | / | / | Glass rod
optic | Glass rod
optic | / | / | SAME |
Table 4-2 Technical comparison for Geared Angle Handpieces
| Item | Proposed Device | Predicate Device | Proposed Device | Predicate Device | Proposed Device | Predicate Device | Proposed Device | Predicate Device | Proposed Device | Predicate Device | Remark | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| (K241074) | (K220179) | (K241074) | (K220179) | (K241074) | (K220179) | (K241074) | (K220179) | (K241074) | (K220179) | (K241074) | (K220179) | (K241074) | (K220179) | (K241074) | (K220179) | ||||||
| Model: | Model: | Model: | Model: | Model: | Model: | Model: | Model: | Model: | Model: | ||||||||||||
| SCHD29-S | CX235-2S | SCHB4 | CX235C3 | SCHB5 | CX235C7 | SCHB20 | CX235C6 | SCHB64 | CX235C8 | ||||||||||||
| Angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | Contra angle | SAME |
13
| Transmission Ratio | 1:1 | 1:1 | 4:1 | 4:1 | 1:5 | 1:5 | 20:1 | 20:1 | 64:1 | 64:1 | SAME |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Speed (rpm) | 50 (200kPa) | > 50 (200kPa) | / | / | > 50 (200kPa) | > 50 (200kPa) | > 50 (200kPa) | > 50 (200kPa) | / | / | SAME |
| Air cooling (L/min) | > 1.5 (200kPa) | > 1.5 (200kPa) | / | / | > 1.5 (200kPa) | > 1.5 (200kPa) | / | / | / | / | SAME |
| LED | / | / | / | / | / | / | / | / | / | / | SAME |
| Fiber | / | / | / | / | Glass rod optic | Glass rod optic | / | / | / | / | SAME |
Analysis 4
The proposed device is different in Speed from the predicate device. However, we tested as ISO 14457 and based on the nonchinical tests performed, the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device.
| Item | Proposed Device (K241074)
Geared Angle Handpieces | Predicate Device (K220179)
Geared Angle Handpieces | Remark |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Coupling
dimensions | Comply with ISO 3964 | Comply with ISO 3964 | SAME |
| Bur extraction force | >32 N | >32 N | SAME |
| Bur type | ISO 1797, type 1, diameter 2.35mm, shaft clamping length: Minimal 11mm,
overall length: max 23mm, blade diameter: max 2mm.
ISO 1797, type 2, diameter 2.35mm, shaft clamping length: Minimal 33mm
overall length: max 50mm, blade diameter: max 2mm. | ISO 1797, type 1, diameter 2.35mm, shaft clamping length: Minimal 11mm,
overall length: max 23mm, blade diameter: max 2mm.
ISO 1797, type 2, diameter 2.35mm, shaft clamping length: Minimal 33mm,
overall length: max 50mm, blade diameter: max 2mm. | SAME |
Table 4-3 Technical comparison for Geared Angle Handpieces
14
| ISO 1797, type 3, diameter1.6mm, shaft cmalping length: Minimal 11mm, overall length: max 23mm, blade diameter: max 2mm. | ISO 1797, type 3, diameter1.6mm, shaft cmalping length: Minimal 11mm, overall length: max 23mm, blade diameter: max 2mm. |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------- |
| Item | Proposed
Device
(K241074)
Model:
SCHD16-M | Predicate
Device
(K220179)
Model:
CX235-3F | Proposed
Device
(K241074)
Model:
SCHD17-M | Predicate
Device
(K220179)
Model:
CX235-3B | Proposed
Device
(K241074)
Model:
SCHD24-M | Predicate
Device
(K220179)
Model:
CX235-3C | Proposed
Device
(K241074)
Model:
SCHD27-M | Predicate
Device
(K220179)
Model:
CX235-3B | Remark |
|-----------------------|-------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------|--------|
| Spray type | External | External | Inner | Inner | Inner | Inner | Inner | Inner | SAME |
| Connector | 4 hole | 4 hole or 2 hole | 4 hole | 4 hole or 2 hole | 6 hole | 6 hole | 4 hole | 4 hole or 2 hole | SAME |
| LED | / | / | / | / | LED (3.3±0.1V) | LED (3.3±0.1V) | / | / | SAME |
| Light intensity | / | / | / | / | > 7000Lux | > 7000Lux | / | / | SAME |
| Fiber | / | / | / | | / | / | / | / | SAME |
| | | | | | | | | | |
| Item | | Proposed Device (K241074)
Air Motors | | | | | Predicate Device (K220179)
Air Motors | | Remark |
| Rotation
speed | | Forward: 20000 | Reverse20000(pm/min at 250 kPa) | / | / | / | 12000-20000rpm at 250 kPa | | SAME |
| Cooling water
flow | | >50 ml/min at 250 kPa | / | / | / | / | >50 ml/min at 250 kPa | | SAME |
Table 5 Technical comparison for Air Motors
15
| Spray air
| source | >1.5 L/min at 250 kPa | >1.5 L/min at 250 kPa | SAME |
|---|---|---|---|
| Coupling | |||
| dimensions | Comply with ISO 3964 | Comply with ISO 3964 |
10. Substantially Equivalent (SE) Conclusion
The conclusions drawn from the nonomical that the device is as safe, as effective, and performs as well as the legally marketed device (K20179).