High Speed Handpieces and Accessories

K152146 · Codent Technical Industry Co., Ltd. · EFB · Dec 8, 2015 · Dental

Device Facts

• Record ID: K152146
• Device Name: High Speed Handpieces and Accessories
• Applicant: Codent Technical Industry Co., Ltd.
• Product Code: EFB · Dental
• Decision Date: Dec 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

High Speed Handpieces and Accessories are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Device Story

Air-powered dental handpieces (45° and 90° angles) used by dentists in clinical settings; connect to dental unit tubes via couplings (2, 4, 5, or 6-hole). Input: compressed air/water from dental unit; output: mechanical rotation of bur for tooth structure removal/polishing. Features include push-button chucks, optional fiber-optic lighting, and cooling spray systems (single/triple/quattro). Device facilitates precise dental preparation and restoration finishing; benefits patient through efficient, controlled removal of dental material.

Clinical Evidence

Bench testing only. Testing included risk management (ISO 14971), hose connectors (ISO 9168), steam sterilization validation (ANSI/AAMI ST79, ISO 17665-1, ISO 11138-3), performance testing (ISO 14457), and biocompatibility (ISO 10993-1, -5, -10). All results met pre-defined acceptance criteria.

Technological Characteristics

Air-powered dental handpieces; materials: stainless steel, brass, aluminum, titanium. 45° or 90° head angles; push-button chuck. Speed: 350,000–400,000 rpm. Cooling: single/triple/quattro spray. Connectivity: pneumatic/water couplings (2/4/5/6-hole). Sterilization: moist heat (autoclave). Standards: ISO 14457:2012, ISO 9168:2009, ISO 10993-1:2009.

Indications for Use

Indicated for dental procedures including removal of carious material, excess filling material, cavity/crown preparation, finishing restorations, root canal preparation, and tooth polishing. No specific patient population age or gender restrictions.

Regulatory Classification

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.

Predicate Devices

• CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS (K033213)

Reference Devices

• 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES (K130455)
• W&H ROTO QUICK COUPLING (K945734)
• TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS (K102517)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 8, 2015

Codent Technical Industry Co., Ltd. Chin-Ting Wen Specialist 5f. No.90, Luke 5th Rd., Luzhu District Kaohsiung City, 82151 TAIWAN

Re: K152146

Trade/Device Name: High Speed Handpieces and Accessories Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: September 7, 2015 Received: September 9, 2015

Dear Chin-Ting Wen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

| 510(k) Number<br>(if know) | K152146 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | High Speed Handpieces and Accessories |
| Indications for Use | High Speed Handpieces and Accessories are<br>intended for removing carious material, excess<br>filling material, cavity and crown preparation,<br>finishing tooth preparations and restorations, root<br>canal preparations and polishing teeth. |

Prescription Use _ X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

# Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) Summary

## 6-1 Submission Date:

July 31, 2015.

### 6-2 Type of 510(k) Submission:

Traditional 510(k)

## 6-3 Submitter Address and Registration:

| Manufacturer: | Codent Technical Industry Co., Ltd |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------|
| Address: | 5F., No.90, Luke 5th Rd., Luzhu Dist., Kaohsiung City<br>821, Southern Taiwan Science Park, Taiwan |
| Phone: | [phone] ext.812 |
| Fax: | [phone] |
| Contact: | Chin-Ting Wen / Specialist |
| Establishment Registration Number: 3004082152 | |

## 6-4 Identification of the Device:

| Device Trade Name | High Speed Handpieces and Accessories |
|-----------------------|---------------------------------------|
| Common Name: | Handpiece, Air-Powered, Dental |
| Classification Name | Dental Handpiece & Accessories |
| Device Classification | 1 |
| Regulation Number | 872.4200 |
| Panel | Dental |
| Product Code | EFB |

## 6-5 Predicate Device Information:

#### Primary Predicate

| Primary Predicate | |
|------------------------|---------------------------------------------------|
| Predicate Device Name: | CODENT DENTAL AIR-POWERED HANDPIECE,<br>MODEL HPS |
| Manufacturer: | Codent Technical Industry Co., Ltd. |
| Product Code: | EFB |
| 510(k) Number: | K033213 |
| Concurrence date | February, 06, 2004 |

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#### Reference Predicate

| Predicate Device Name: | 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES |
|------------------------|------------------------------------------------|
| Manufacturer: | DENTALEZ GROUP, STARDENTAL DIVISION |
| Product Code: | EFB |
| 510(k) Number: | K130455 |
| Concurrence date | September, 25, 2013 |

#### Reference Predicate

| Predicate Device Name: | W&H ROTO QUICK COUPLING |
|------------------------|-------------------------|
| Manufacturer: | A-DEC, INC. |
| Product Code: | EFB |
| 510(k) Number: | K945734 |
| Concurrence date | October, 05, 1995 |

#### Reference Predicate

| Predicate Device Name: | TIGER 500 SERIES HIGH SPEED HANDPIECES AND<br>ATTACHMENTS |
|------------------------|-----------------------------------------------------------|
| Manufacturer: | THUNDER TIGER CORP. |
| Product Code: | EFB |
| 510(k) Number: | K102517 |
| Concurrence date | April, 27, 2011 |

### 6-6 Intended Use and Indications for Use of the Subject Device:

High Speed Handpieces and Accessories are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

## 6-7 Device Description:

High Speed Handpieces and Accessories include 45° High Speed Handpieces, 90° High Speed Handpieces and Couplings. The device description of High Speed Dental Handpieces and Accessories are as follows.

The models of 45° High Speed Handpieces are A45series (A45L, A45, A45M4) and 90° High Speed Handpieces are A6series (A6KL, A6L, A6, A6M4, A6B2), A5series (A5KL, A5K, A5L, A5, A5M4, A5B2), A4series (A4, A4M4, A4B2), A3series (A3, A3M4, A3B2), E-6510series (E-6510K, E-6510N), E-6500series (E-6500K, E-6500N), E-6110series (E-6110K, E-6110N), E-6100series (E-6100K, E-6100N), HPXseries (HPX4CML-Ti, HPX4CQ, HPX4CQ-Ti), HPMseries (HPM1CML, HPM1CQ, HPM1C4, HPM1C2, HPM1S4, HPM1S2) and HPKseries (HPK1C2, HPK1S4, HPK1S2). And the accessories of High Speed Handpiece are Couplings, the models of Accessories are

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Q6series (Q6M, Q6M-LED, Q6K, Q6K-LED, Q6KW), Q5series (Q5K), Q4series (Q4K, Q4M, Q4Q), Q2series (Q2Q), CKseries (CK4010, CK4000) and CNseries (CN4010, CN4000)

Concerning the head of handpiece and angle of shaft, the handpiece could be 45° or 90° . In general, dentist usually uses 90° handpiece having teeth treatment. Except for wisdom teeth, 45° handpiece is considered more desirable for wisdom teeth operation. It is because the 45° angle is more appropriate for the angle of eruption of wisdom teeth. Coupling is the accessory for handpiece to connect with tubes of dental unit. It could be divided into four types. There are 2-hole coupling (drive air and spray water holes), 4hole coupling (drive air, exhaust air, spray air and spray water holes), 5-hole coupling (drive air, exhaust air, spray air and spray water and fibre optic holes) and 6-hole coupling (drive air, exhaust air, spray air, spray water and two of electrical contacts holes). The use of the coupling of handpiece is due to the number of tubes of dental unit.

- Cooling system includes single, triple and quattro spray.
- Head size of high speed handpiece has standard, miniature and torque head.
- 45° High Speed Handpieces are able to run 360,000 rpm±10% amd 90° High Speed
- Handpieces are able to run 400,000 rpm±10%.
- A45L, A6KL, A5KL, A6L, A5L, E-6510K, E-6510N, E-6110K, E-6110K, E-6110N, ● HPX4CML-Ti and HPM1CML have light function.
- Q2Q and Q4Q assemble with A6, A5, A4, A3, A45, HPX4CQ, HPS3CQ, HPS1CQ, HPM1CQ and HPX4CQ-Ti. Q5K, Q6K, Q6K-LED and Q6KW assemble with A6KL, A6K, A5KL and A5K. Q6M and Q6M-LED assemble with A6L, A5L, A45L, HPX4CML-Ti, HPS3CML and HPM1CML. Q4M assembles with HPS3CM. Q4K assembles with A6K and A5K. CK-4010 assembles with E-6510K and E-6110K. CK-4000 assembles with E-6500K and E-6100K. CN-4010 assembles with E-6510N and E-6110N. CN-4000 assembles with E-6500N and E-6100N.

## 6-8 Substantial Equivalent Devices :

The High Speed Handpieces and Accessories submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the devices cleared in K033213, K013455, K945764 and K102517. In the chart below, the entire intended use for all predicate devices is listed, but it should be noted that the proposed device has SE with CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS and 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES, W&H ROTO QUICK COUPLING and TIGER 500 SERIES HIGH SPEED HANDPIECES

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## AND ATTACHMENTS.

Differences between the devices cited in this section do not raise any new questions of safety or effectiveness.

## Comparison of Technical Features

| Item | Proposed Device | Primary<br>Predicate<br>Device<br>(K033213) | Reference<br>Predicate<br>Device<br>(K130455) | Reference<br>Predicate<br>Device<br>(K945734) | Reference<br>Predicate<br>Device<br>(K102517) |
|------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| | | Similarity | | | |
| Classification | Class I | Class I | Class I | Class I | Class I |
| Code or Federal<br>Regulations | 872.4200 | 872.4200 | 872.4200 | 872.4200 | 872.4200 |
| Product Code | EFB | EFB | EFB | EFB | EFB |
| Over-the-counter<br>Medical Device | No | No | No | No | No |
| | | Device design | | | |
| Operational modes | Air-powered | Air-powered | Air-powered | Air-powered | Air-powered |
| Water spray | Single/Triple/ | Single/Triple | Single | N/A | N/A |
| Coupling pin | 2-pin/4-pin/5-<br>pin/ | 2-pin/4-pin/6-pin | 4-pin/6-pin | 2-pin/4-pin/6-pin | 5-pin |
| Fiber optics | With light/<br>Without light | With light/<br>Without light | With light/<br>Without light | With light/<br>Without light | With light |
| Dimensions(mm) | Length: 84~117<br>Width: 19~21 | Length: 84~117<br>Width: 19~21 | unknown | N/A | N/A |
| Accessories | with coupling/<br>without coupling | with coupling/<br>without coupling | with coupling | N/A | N/A |
| Composition of main<br>materials | Stainless<br>steel,<br>Brass,<br>Aluminum,<br>Titanium | Stainless<br>steel,<br>Brass,<br>Aluminum,<br>Titanium | unknown | unknown | unknown |
| Technical specifications | | | | | |
| Chunk design | Push<br>Button | Push<br>Button | Push Button<br>Chuck | N/A | N/A |
| Light intensity | 25,000 lux to<br>32,000 | 25,000 lux to<br>32,000 | unknown | N/A | N/A |
| Bur extraction force | 22N~45N | 22N~45N | 22N~45N | N/A | N/A |
| Maximum air/water<br>pressure | air: 1.5 l/min<br>at<br>200kPa<br>(2bar)<br>water: 50ml/min | air: 1.5 l/min<br>at<br>200kPa<br>(2bar)<br>water: 50ml/min | air: 1.5 l/min<br>at<br>200kPa<br>(2bar)<br>water: 50ml/min | N/A | N/A |
| Speed in rpms | 350,000 rpm<br>to<br>400,000rp<br>m | 350,000 rpm<br>to<br>380,000rp<br>m | 400,000rpm | N/A | N/A |

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| Intended Use | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proposed Device | High Speed Handpieces and Accessories are intended for removing<br>carious material, excess filling material, cavity and crown<br>preparation, finishing tooth preparations and restorations, root canal<br>preparations and polishing teeth. |
| Primary Predicate<br>Device<br>(K033213) | Codent Dental Air-Powered Handpiece, model HPS is intended for<br>removing carious material, reducing hard tooth structure, cavity<br>preparation, finishing tooth preparations and restorations and<br>polishing teeth. |
| Reference Predicate<br>Device<br>(K130455) | The 430 SWL 45 High-Speed Handpiece is a fiber optic, swive<br>connector type handpiece with a lubefree, ceramic bearing, and<br>push button autochuck turbine. The 430 SW 45 High-Speed<br>Handpiece is a non-fiber optic version of the 430 SWL 45<br>Handpiece. |
| Reference Predicate<br>Device<br>(K945734) | Unknown |
| Reference Predicate<br>Device<br>(K102517) | Tiger 500 Series High Speed Handpieces are intended for removing<br>carious material, reducing hard tooth structure, cavity preparation,<br>finishing tooth preparations and restorations and polishing teeth. |
| Models | |
| Proposed Device | High Speed Handpiece<br>- A45series: A45L, A45, A45M4<br>- A6series: A6KL, A6K, A6L, A6, A6M4, A6B2<br>- A5series: A5KL, A5K, A5L, A5, A5M4, A5B2<br>- A4series: A4, A4M4, A4B2<br>- A3series: A3, A3M4, A3B2<br>- E-6510series: E-6510K, E-6510N<br>- E-6500series: E-6500K, E-6500N<br>- E-6110series: E-6110K, E-6110N<br>- E-6100series: E-6100K, E-6100N<br>- HPXseries: HPX4CML-Ti, HPX4CQ, HPX4CQ-Ti<br>- HPMseries: HPM1CML, HPM1CQ, HPM1C4, HPM1C2, |
| | HPM1S4, HPM1S2 |
| | HPKseries: HPK1C4, HPK1C2, HPK1S4, HPK1S2 |
| | Accessories |
| | Q6series: Q6M, Q6M-LED, Q6K, Q6K-LED, Q6KW |
| | Q5series: Q5K |
| | Q4series: Q4K, Q4M, Q4Q |
| | Q2series: Q2Q |
| | CKseries: CK4010, CK4000 |
| | CNseries: CN4010, CN4000 |
| Predicate Device<br>(K033213) | HPS3CML, HPS3CQ, HPS1CQ, HPS3C4, HPS3CM and HPS3C2. |
| Reference Predicate<br>Device (K130455) | 430 SWL 45 and 430 SW 45. |
| Reference Predicate<br>Device (K945734) | RQ03, RQ04, RQ24 and RQ34 |
| Reference Predicate<br>Device (K102517) | QC5015K |
| Standards | |
| Proposed Device | ISO 14971:2007, ISO 9168:2009, ANSI/AAMI<br>ST79:2010/A3:2012, ISO 14457:2012, ISO 10993-1:2009. |
| Primary Predicate<br>Device (K033213) | ISO 7785-1:1997, ISO 13294:1997, ISO, ISO 9168:2009, ISO<br>14971:2007, ANSI/AAMI ST79:2010/A3:2012, ISO 14457:2012,<br>ISO 10993-1:2009. |
| Reference Predicate<br>Device (K130455) | ISO 7785-1:1997, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011,<br>AAMI/ANSI/ISO 14937:2009 and ISO 14971:2009. |
| Reference Predicate<br>Device (K945734) | Unknown |
| Reference Predicate<br>Device (K102517) | ISO 7785-1:1997 |

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The Standards of ISO 7785-1:1997 and ISO 13294:1997 that K033213, K130455 and K102517 used are canceled and replaced by ISO 14457:2012 according to the ISO 14457:2012.

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## 6-9 Non-clinical Testing:

The tests listed below were conducted for High Speed Handpieces and Accessories in accordance with the following standards.

- ISO 14971:2007 Medical devices Application of risk management to medical ● devices
- ISO 9168:2009 Dentistry Hose connectors for air driven dental handpieces ●
- ANSI/AAMI ST79:2010/A3:2012 Comprehensive guide to steam sterilization and ● sterility assurance in health care facilities, Amendment 3
- . AAMI/ANSI/ISO 17665-1:2006/(R)2013 – 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 11138-3:2006 - Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat
- ISO 14457:2012 Dentistry - Handpieces and Motors
- . ISO 10993-1:2009 - Biological Evaluation of Medical Devices - Part 1: EvaluationAnd Testing Within A Risk Management Process
- . ISO10993-5:2009 – Biological evaluation of medical devices – tests for in vitro cytotoxicity
- . ISO 10993-10:2010 - Biological evaluation of medical devices - tests for intracutaneous irritation and skin sensitization
- Guidance for Industry and FDA Staff-Dental Handpieces-Premarket . Notification[510(k)] Submissions

All the test results demonstrate the performance of High Speed Handpieces and Accessories meets the requirements of its pre-defined acceptance criteria and intended uses. Differences in device design, such as type of water spray, small dimensional differences for head and/or length. maximum rpm. have no impact on the usability and function of the proposed devices. Conformity with the above standards also demonstrates that the High Speed Handpieces and Accessories are substantially equivalent to the predicate devices.

## 6-10 Conclusion:

After analyzing bench testing data, and considering conformance to consensus standards recognized by FDA in terms of risk, connectors, sterilization, biocompatibility, and FDA guidance, it can be concluded that High Speed Handpieces and Accessories is substantially equivalent to the predicate devices.