Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are for mechanical dental handpieces and accessories, with no mention of software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical and sterilization standards.

Therapeutic

Yes.
The device is intended for "removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth," which are all therapeutic interventions on teeth.

Diagnostic

No

Explanation: The device is a high-speed handpiece used for mechanical tasks like removing material, preparing cavities, and polishing teeth. Its intended uses do not involve diagnosing conditions or providing diagnostic information.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components like "High Speed Handpieces" and "Couplings," which are hardware, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used for mechanical procedures on teeth (removing material, preparing cavities, polishing, etc.). This is a direct intervention on the patient's body.
Device Description: The description details mechanical handpieces and couplings, which are tools for physical manipulation.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in a laboratory or clinical setting to analyze biological samples.

The device described is a dental handpiece, which is a surgical/dental instrument used for direct treatment of the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

EFB

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 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.

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K033213, K130455, K945734, K102517

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

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.

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

Indications for Use Statement

| 510(k) Number

(if know)	K152146
Device Name	High Speed Handpieces and Accessories
Indications for 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.

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)

3

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
821, Southern Taiwan Science Park, Taiwan
Phone:	+886-7-695-5533 ext.812
Fax:	+886-7-695-5683
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,
MODEL HPS
Manufacturer:	Codent Technical Industry Co., Ltd.
Product Code:	EFB
510(k) Number:	K033213
Concurrence date	February, 06, 2004

4

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
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

5

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

6

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
Predicate
Device
(K033213) | Reference
Predicate
Device
(K130455) | Reference
Predicate
Device
(K945734) | Reference
Predicate
Device
(K102517) |
|------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|
| | | Similarity | | | |
| Classification | Class I | Class I | Class I | Class I | Class I |
| Code or Federal
Regulations | 872.4200 | 872.4200 | 872.4200 | 872.4200 | 872.4200 |
| Product Code | EFB | EFB | EFB | EFB | EFB |
| Over-the-counter
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-
pin/ | 2-pin/4-pin/6-pin | 4-pin/6-pin | 2-pin/4-pin/6-pin | 5-pin |
| Fiber optics | With light/
Without light | With light/
Without light | With light/
Without light | With light/
Without light | With light |
| Dimensions(mm) | Length: 84117
Width: 1921 | Length: 84117
Width: 1921 | unknown | N/A | N/A |
| Accessories | with coupling/
without coupling | with coupling/
without coupling | with coupling | N/A | N/A |
| Composition of main
materials | Stainless
steel,
Brass,
Aluminum,
Titanium | Stainless
steel,
Brass,
Aluminum,
Titanium | unknown | unknown | unknown |
| Technical specifications | | | | | |
| Chunk design | Push
Button | Push
Button | Push Button
Chuck | N/A | N/A |
| Light intensity | 25,000 lux to
32,000 | 25,000 lux to
32,000 | unknown | N/A | N/A |
| Bur extraction force | 22N~~45N | 22N~~45N | 22N~45N | N/A | N/A |
| Maximum air/water
pressure | air: 1.5 l/min
at
200kPa
(2bar)
water: 50ml/min | air: 1.5 l/min
at
200kPa
(2bar)
water: 50ml/min | air: 1.5 l/min
at
200kPa
(2bar)
water: 50ml/min | N/A | N/A |
| Speed in rpms | 350,000 rpm
to
400,000rp
m | 350,000 rpm
to
380,000rp
m | 400,000rpm | N/A | N/A |

7

Intended Use
Proposed 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.
Primary Predicate
Device
(K033213)	Codent Dental Air-Powered Handpiece, model HPS is intended for
removing carious material, reducing hard tooth structure, cavity
preparation, finishing tooth preparations and restorations and
polishing teeth.
Reference Predicate
Device
(K130455)	The 430 SWL 45 High-Speed Handpiece is a fiber optic, swive
connector type handpiece with a lubefree, ceramic bearing, and
push button autochuck turbine. The 430 SW 45 High-Speed
Handpiece is a non-fiber optic version of the 430 SWL 45
Handpiece.
Reference Predicate
Device
(K945734)	Unknown
Reference Predicate
Device
(K102517)	Tiger 500 Series High Speed Handpieces are intended for removing
carious material, reducing hard tooth structure, cavity preparation,
finishing tooth preparations and restorations and polishing teeth.
Models
Proposed Device	High Speed Handpiece

A45series: A45L, A45, A45M4
A6series: A6KL, A6K, 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 |
| | 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
(K033213) | HPS3CML, HPS3CQ, HPS1CQ, HPS3C4, HPS3CM and HPS3C2. |
| Reference Predicate
Device (K130455) | 430 SWL 45 and 430 SW 45. |
| Reference Predicate
Device (K945734) | RQ03, RQ04, RQ24 and RQ34 |
| Reference Predicate
Device (K102517) | QC5015K |
| Standards | |
| Proposed Device | ISO 14971:2007, ISO 9168:2009, ANSI/AAMI
ST79:2010/A3:2012, ISO 14457:2012, ISO 10993-1:2009. |
| Primary Predicate
Device (K033213) | ISO 7785-1:1997, ISO 13294:1997, ISO, ISO 9168:2009, ISO
14971:2007, ANSI/AAMI ST79:2010/A3:2012, ISO 14457:2012,
ISO 10993-1:2009. |
| Reference Predicate
Device (K130455) | ISO 7785-1:1997, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011,
AAMI/ANSI/ISO 14937:2009 and ISO 14971:2009. |
| Reference Predicate
Device (K945734) | Unknown |
| Reference Predicate
Device (K102517) | ISO 7785-1:1997 |

8

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.

9

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.