The Codent Low Speed Dental 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 Description

Codent Low Speed Dental Handpieces and Accessories include low speed air motor, straight handpiece and contra-angle handpiece. The Codent Low Speed Dental 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.

The gear ratios of handpieces are 1:5 and 1:1, with the maximum speed of 200,000 rpm and 40,000 rpm. AI4C and AI2N air motors can be connected to LAISAI, LBIPA1, LEIPD4 and LEIPC4 hanpieces. AE4N and AE2N air motors can be connected to LAESA2 and LDEPA2 hanpieces. The 4 air motors are capable of running up to a speed of 25,000 rpm.

AI/ML Overview

This looks like a 510(k) summary for a dental handpiece, not an AI/ML medical device. The document describes traditional medical device testing and regulatory approval processes based on substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria for an AI/ML product.

Therefore, I cannot provide the requested information for an AI/ML device because the provided text does not describe an AI/ML device or its associated studies.

However, I can extract information related to the device's performance testing and comparison to predicates, as presented in the document, even though it doesn't align with the AI/ML specific questions.

Here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with explicit acceptance criteria values alongside device performance values. Instead, it states that "All the test results demonstrate the performance of Codent Low Speed Dental Handpieces and Accessories meets the requirements of its pre-defined acceptance criteria and intended uses." The acceptance criteria are implicitly those established by the standards listed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any of the non-clinical tests. It only lists the standards in accordance with which the tests were conducted (e.g., ISO 7785-2:1995, ISO 13294:1997). There is no mention of data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these concepts are not applicable to the non-clinical, bench testing described for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to the type of testing described. The "ground truth" for a dental handpiece's performance is established by its compliance with recognized industry standards for mechanical, electrical, and biological safety, not by expert consensus on interpretations of data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are typically used in clinical trials or studies involving human judgment, not for the non-clinical bench testing of a dental handpiece.

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 is not applicable as the device is a dental handpiece, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a physical dental handpiece, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device, in the context of its safety and effectiveness, is its compliance with international and national standards (e.g., ISO, ANSI/AAMI) for dental handpieces, air motors, and sterilization. These standards define the acceptable performance characteristics and safety profiles.

8. The sample size for the training set

This is not applicable. The device is a physical dental handpiece and does not utilize a training set in the AI/ML sense.

9. How the ground truth for the training set was established

This is not applicable for the same reason as above.

Summary of what the document DOES discuss regarding performance and acceptance:

The document states that the Codent Low Speed Dental Handpieces and Accessories underwent "Non-clinical Testing" in accordance with several standards, including:

ISO 7785-2:1995 Dental Handpiece Part 2: straight & Geared Angle Handpieces
ISO 13294:1997 Dental Handpiece Dental Air Motors
ISO 3964:1982 Dental Handpieces Coupling Dimensions
ISO 1797-1: 2011 Dentistry Shanks for Rotary Instruments Part 1: Shanks Made of Metals
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
ISO 14457:2012 Dentistry Handpieces and Motors
Guidance for Industry and FDA Staff-Dental Handpieces-Premarket Notification [510(k)] Submissions
ISO 10993-1:2009, Biological Evaluation of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process

The report concludes: "All the test results demonstrate the performance of Codent Low Speed Dental Handpieces and Accessories meets the requirements of its pre-defined acceptance criteria and intended uses. Conformity with the above standards also demonstrates that the Codent Low Speed Dental Handpieces and Accessories are as safe and effective as the predicate devices."

Summary

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.

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

October 24, 2014

Codent Technical Industry Company Limited Chin-Ting Wen Specialist 5F., No. 90, Luke 5th Road, Luzhu District Southern Taiwan Science Park Kaohsiung City 82151 TAIWAN

Re: K133069

Trade/Device Name: Codent Low Speed Dental Handpieces and Accessories Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: I Product Code: EFB. EGS Dated: September 19, 2014 Received: September 22, 2014

Dear Mr. 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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Page 2 - Mr. Wen

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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

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Indications for Use

510(k) Number (if known): K133069

Device Name: Codent Low Speed Dental Handpieces and Accessories

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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510(k) Summary

1. Type of Submission: Traditional
1. Revised Date: 2013/12/31

3.	Submitter:	CODENT TECHNICAL INDUSTRY Co., Ltd
	Address:	5F., No.90, Luke 5th Rd., Luzhu Dist., Kaohsiung City 821, Taiwan (R.O.C.)
	Phone:	+886-7-6955-533 ext.812
	Fax:	+886-7-6955-683
	Contact:	Chin-Ting Wen / Specialist
	Establishment Registration Number:	3004082152

4. Identification of the Device:

Proprietary/Trade name:	Codent Low Speed Dental Handpieces andAccessories
Common Name:	Air-Powered Dental Handpieces & Contra- AnRight-Angle Attachment
Classification Name:	Dental Handpiece & Accessories
Device Classification:	1
Regulation Number:	872.4200
Panel:	Dental
Product Code:	EFB/EGS

Identification of the Predicate Device: 5.

Predicate Device Name:	A-dec/W&H Synea Air-Driven HighspeedHandpiece, Models TA-98, TA-97A-dec/W&H Synea Handpiece Attachment,Models WA-99LT, WA-86LT, WA-66LT,WA-56LT, HA-43LT
Manufacturer:	A-DEC, INC.
510(k) Number:	K070663
Predicate Device Name:	Premium Slow Speed Dental Handpieces andAccessories
Manufacturer:	Sable Industries, Inc.

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510(k) Number: K083101

Intended Use and Indications for Use of the subject device. 6.

Codent Low Speed Dental 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.

7. Device Description

8. Non-clinical Testing

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

ISO 7785-2:1995 Dental Handpiece Part 2: straight & Geared Angle Handpieces .
ISO 13294:1997 Dental Handpiece Dental Air Motors .
ISO 3964:1982 Dental Handpieces Coupling Dimensions .
ISO 1797-1: 2011Dentistry Shanks for Rotary Instruments Part 1: Shanks Made . of Metals
. 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
ISO 14457:2012 Dentistry Handpieces and Motors .
. Guidance for Industry and FDA Staff-Dental Handpieces-Premarket Notification [510(k)] Submissions
. ISO 10993-1:2009, Biological Evaluation of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process

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All the test results demonstrate the performance of Codent Low Speed Dental Handpieces and Accessories meets the requirements of its pre-defined acceptance criteria and intended uses. Conformity with the above standards also demonstrates that the Codent Low Speed Dental Handpieces and Accessories are as safe and effective as the predicate devices.

9. Substantial Equivalence Determination

The Codent Low Speed Dental 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 K070663 and K083101. In the chart below, the entire intended use for all predicate devices are listed, but it should be noted that the proposed device has SE with A-dec/W&H Synea Handpiece Attachment (not A-dec/W&H Synea Air-Driven Highspeed Handpiece, models TA-98, TA-97) and Premium Slow Speed Dental Handpieces and Accessories.

Intended Use
Proposed Device	The Codent Low Speed Dental Handpieces and Accessories are intendedfor removing carious material, excess filling material, cavity and crownpreparation, finishing tooth preparations and restorations, root canalpreparations and polishing teeth.
Predicate Device(K083101)	Sable Industries Premium Slow Speed Dental & Accessories areindicated for use in general dentistry for cleaning and polishing of teeth.
Predicate Device(K070663)	The A-dec/W&H Synea Air-Driven Highspeed Handpiece is anair-powered dental handpiece for use in general dentistry. This device isdesigned for removing carious material and excess filling material,cavity and crown preparation, root canal preparations, finishing toothpreparations, restorations and polishing teeth.The A-dec/W&H Synea Handpiece Attachment is powered by either anair-motor or electric micromotor for use in general dentistry. This deviceis designed for removing carious material and excess filling material,cavity and crown preparation, root canal preparations, finishing toothpreparations, restorations and polishing teeth.
Models
Proposed Device	LAISA1, LBIPA1, AI4C, AI2N, LAESA2, LDEPA2, AE4N, AE2N,LEIPD4, LEIPC4
Predicate Device(K083101)	p/n 1610101, p/n 1610801, p/n 1610801, p/n 1600411, p/n 1600508, p/n1610299, p/n 1610201, p/n 1610301

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

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Predicate Device	WA-99LT, WA-86LT, WA-66LT, WA-56LT, HA-43LT
(K070663)
Standards
Proposed Device	ISO 7785-2:1995, ISO 13294:1997, ISO 3964:1982, ISO 1797-1:
	2011 ,ISO 9168:2009, ISO 14971:2007, ANSI/AAMI
	ST79:2010/A3:2012, ISO 14457:2012, ISO 10993-1:2009
Predicate Device	ISO 13294, ISO 7785-2, ISO 9168, ISO 17665-1, ISO 11134,
(K083101)	ISO 10993-1
Predicate Device	Unknown
(K070663)

More comparative items are listed in Section of Equivalence Discussion.

10. Conclusion

After analyzing bench tests and safety testing data, it can be concluded that Codent Low Speed Dental Handpieces and Accessoriesis substantially equivalent to the predicate devices.

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.