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 gear ratios of handpieces are 1:5 and 1:1. The handpieces have maximum speed of 200,000 rpm and minimum speed of 40,000 rpm. The air motors are capable of running up to a speed of 25,000 rpm. AI6C and AI2C air motors can be connected to LEIPB1, LEIPA1, A11, A65L, A65, A61L and A61 handpieces; LAISA1, LBIPA1, LEIPD4 and LEIPC4 of Codent's FDA 510(k) K133069. E-1110 and E-1100 air motors can be connected to E-2000. E-4010 and E-4000 handpieces.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a predicate device. It primarily focuses on comparing the new device, "Codent Low Speed Dental Handpieces and Accessories," to a previously cleared device (K133069) from the same manufacturer. While it describes modifications and design comparisons, it does not contain the specific information requested about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert evaluations in the manner typically found in a clinical study report for an AI/ML powered device.

The document discusses bench testing conducted to ensure that design changes do not "cause any actual performance impact" or "additional risk" compared to the predicate device. This type of testing is often used to demonstrate that the new device maintains the safety and effectiveness characteristics of the predicate, but it is not a clinical study involving human subjects or expert readers for diagnostic/AI performance evaluation.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to the clinical validation of AI/ML devices, which is not the subject of this 510(k) submission for a non-AI/ML dental handpiece.

Here's an attempt to answer based on the provided text, highlighting what is missing:

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

The document does not explicitly state formal "acceptance criteria" in a quantitative, measurable way for clinical performance metrics often seen with AI/ML devices, nor does it provide detailed performance results in the context of a clinical study. Instead, it relies on demonstrating that the modified device's functionality and performance are the same as or equivalent to the predicate device through bench testing for various physical and functional characteristics.

The "reported device performance" is essentially that the device functions as expected and does not introduce new risks compared to the predicate, as evidenced by the bench testing. No specific numerical performance values (e.g., accuracy, sensitivity, specificity) against a clinical ground truth are reported.

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

This information is not provided. The document refers to "bench testing," which implies laboratory-based evaluations rather than testing on a clinical dataset or patient information. Therefore, there is no "test set" in the context of clinical data.

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 information is not applicable and not provided. The device is a dental handpiece, not a diagnostic tool requiring expert interpretation or ground truth establishment based on clinical findings.

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

This information is not applicable and not provided for the reasons stated above.

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

No such study was done or reported. This device is a mechanical dental handpiece and does not utilize AI.

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

Not applicable. This device is a mechanical product, not an algorithm.

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

Not applicable. The "ground truth" for this type of device relates to engineering specifications and safety standards, confirmed through bench testing, rather than clinical outcomes or diagnoses. The safety and basic functionality are compared to the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve AI or machine learning, so there is no training set.

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

Not applicable. There is no training set for this device.

Summary of the Study and Device Meeting Acceptance Criteria (as per the document):

The "study" conducted for this 510(k) submission is primarily non-clinical bench testing. The purpose was to demonstrate that modifications to the Codent Low Speed Dental Handpieces and Accessories (K150798) do not negatively impact safety and performance, and that the device remains substantially equivalent to its predicate (K133069).

The modifications include:

Changing shaft materials from Brass to Aluminum (Aluminum was already used in the sleeve of the predicate).
Adding new models for market segmentation.
Adding LED light function in some air motor models.
Adding 2-hole air motor design to comply with 2-hole dental units.

The document claims the device meets acceptance criteria by stating:

Risk Assessment: The material change (Aluminum shaft) poses no biocompatibility risk as Aluminum was already used in the predicate's sleeve. The low voltage/current for LED/Halogen lamps does not cause high-temperature risk. The 2-hole air motor design is just a pipeline route difference and does not change functionality, performance, or introduce additional risk.
Functionality and Performance Test Results: Bench testing was executed covering "drop, noise, air supply, spray air supply, water supply, air and water pressure stability, temperature, vibrations, resistance to reprocessing, operating control, usability, chuck system for shanks, speed, eccentricity, torque and the experiment of illumination." The conclusion is that "the changes of design don't affect the functionality and performance test results that would not cause additional risk."

In essence, the "acceptance criteria" here implicitly refer to maintaining the safety and performance characteristics of the predicate device, as confirmed through engineering and functional bench tests rather than clinical trials with specific diagnostic or therapeutic efficacy endpoints.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

April 24, 2015

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

Re: K150798

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 Codes: EFB, EGS Dated: March 16, 2015 Received: March 26, 2015

Dear Mr. Chin-Ting:

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. Isting 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 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/ResourcesforYou/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.

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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Section 6 Indications for Use Statement

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Indications for Use Statement

510(k) Number(if know)	K150798
Device Name	Codent Low Speed Dental Handpieces andAccessories
Indications for Use	Codent Low Speed Dental Handpieces andAccessories are intended for removing cariousmaterial, excess filling material, cavity and crownpreparation, finishing tooth preparations andrestorations, root canal preparations and polishing

Prescription Use	AND/OR	Over-The-Counter Use
X
(Per 21 CFR 801 Subpart D)		(Per 21 CFR 801 Subpart C)

teeth.

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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Section 7

510(k) Summary

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510(k) Summary

7-1 Submission Date:

Apr 02, 2015.

7-2 Type of 510(k) Submission:

Special 510(k) K150798

7-3 Submitter Address and Registration:

Manufacturer:	Codent Technical Industry Co., Ltd
Address:	5F., No.90, Luke 5th Rd., Luzhu Dist., Kaohsiung City821, 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

7-4 Identification of the Device:

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

7-5 Predicate Device Information:

Predicate Device Name:	Codent Low Speed Dental Handpieces and Accessories
Manufacturer:	Codent Technical Industry Co., Ltd.
Product Code:	EFB/EGS
510(k) Number:	K133069
Concurrence date	October 24, 2014

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7-6 Intended Use and Indications for Use of the Subject Device:

7-7 Device Description and Comparison with Predicate Device:

7-7-1 Device Description

Codent Low Speed Dental Handpieces and Accessories include low speed air motor, straight handpiece and contra-angle handpiece. The device description of the Codent Low Speed Dental Handpieces and Accessories is as follows.

The gear ratios of handpieces are 1:5 and 1:1
The handpieces have maximum speed of 200,000 rpm and minimum speed of 40,000 rpm.
The air motors are capable of running up to a speed of 25,000 rpm.
AI6C and AI2C air motors can be connected to LEIPB1, LEIPA1, A11, A65L, A65, A61L and A61 handpieces; LAISA1, LBIPA1, LEIPD4 and LEIPC4 of Codent's FDA 510(k) K133069.
E-1110 and E-1100 air motors can be connected to E-2000. E-4010 and E-4000 handpieces.

7-7-2 The Modification of the Subject Device

The only modifications that were made are:

Adding new models of Codent Low Speed Handpiece that the shaft materials of Codent Low Speed Dental Handpieces are different from the shaft materials of the K133069, but the same materials of the sleeve materials of K133069.
Adding new models for market segment that are not change any of the design of Codent Low Speed Dental Handpieces and accessories of K133069.
Adding a new model that has LED light function in Air Motor, the accessories of Codent Low Speed Dental Handpieces.
Adding a new model that only has 2 holes of Air Motor, the accessories of Codent Low Speed Dental Handpieces, to comply with 2 holes dental unit needed.

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7-7-1 The same and the different technological characteristics comparison with Predicate Device K133069

The same and the different technological characteristics comparison with Predicate Device K133069 as follows:

A Subject Device (Model: A11) comparison with Predicate Device LAISA1 and LDEPA2:

The same technological characteristics: -
- The Subject Device, Model: A11 has the same intended use, device design (Operational modes, Cooling System, Fiber optics, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Light intensity, Bur extraction force, Maximum air/water pressure, Speed in rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: LAISA1.
- . Iin comparison to other Predicate Device Model: LDEPA2, the Shaft materials of A11 are the same as the materials that LDEPA2 used in Sleeve that sleeve and shaft are the same as the hand-held parts of handpieces.
The difference technological characteristics: -
- The only difference is device design between the Subject Device, Model: A11 and Predicate Device, Model: LAISA1 that the materials used in Shaft. The Shaft materials of A11 is Aluminum (Coating Materials: Aluminum (Anodizing) / Coating Range: Parts Appearance), but LAISA1 is Stainless Steel (Coating Materials: None / Coating Range: Parts Appearance).

> Subject Device (Model: E-2000) comparison with Predicate Device LAISA1 and LDEPA2:

The same technological characteristics: -
- The Subject Device, Model: E-2000 has the same intended use, device design (Operational modes, Cooling System, Fiber optics, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Light intensity, Bur extraction force, Maximum air/water pressure, Speed in

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rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: LAISA1.

In comparison to other Predicate Device Models, Model: LDEPA2, the Shaft materials of E-2000 are the same as the materials that LDEPA2 used in Sleeve that sleeve and shaft are the same as the hand-held parts of handpieces.
The difference technological characteristics: -
- . The only difference between the Subject Device, Model: E-2000 and Predicate Device, Model: LAISA1 is the device design that the materials used in Shaft. The Shaft materials of E-2000 is Aluminum (Coating Materials: Aluminum (Anodizing) / Coating Range: Parts Appearance), but LAISA1 is Stainless Steel (Coating Materials: None / Coating Range: Parts Appearance).

A Subject Device (Model: A61L) comparison with Predicate Device LBIPA1 and LDEPA2

-The same technological characteristics:
- . The Subject Device, Model: A61L has the same intended use, device design (Operational modes, Cooling System, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Bur extraction force, Maximum air/water pressure, Speed in rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: LBIPA1.
- In comparison to other Predicate Device Models, Model: LDEPA2, the Shaft ■ materials of A61L are the same as the materials that LDEPA2 used in Sleeve that sleeve and shaft are the same as the hand-held parts of handpieces.
- The device design of the A61L is the same as the Predicate Device, Model: LEIPD4.
-The difference technological characteristics:
- The difference device design between the Subject Device, Model: A61L and Predicate Device, Model: LBIPA1 are the materials used in Shaft and Fiber optics Light Function. The Shaft materials of A61L is Aluminum (Coating Materials: Aluminum (Anodizing) / Coating Range: Parts Appearance), but

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LBIPA1 is Brass (Coating Materials: Titanium / Coating Range: Parts Appearance). And the A61L has the Fiber optics Light Function but LBIPA1 hasn't.

Subject Device (Model: A61) comparison with Predicate Device LBIPA1 and A LDEPA2:

The same technological characteristics: A
- The Subject Device, Model: A61 has the same intended use, device design (Operational modes, Cooling System, Fiber optics, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Light intensity, Bur extraction force, Maximum air/water pressure, Speed in rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: LBIPA1.
- In comparison to other Predicate Device Models, Model: LDEPA2, the Shaft materials of A61 are the same as the materials that LDEPA2 used in Sleeve that sleeve and shaft are the same as the hand-held parts of handpieces.
The difference technological characteristics: -
- But the only difference in the device design between Subject Device, Model: A61 and Predicate Device, Model: LBIPA1 is the materials used in Shaft. The Shaft materials of A61 is Aluminum (Coating Materials: Aluminum (Anodizing) / Coating Range: Parts Appearance), but LBIPA1 is Brass (Coating Materials: Titanium / Coating Range: Parts Appearance).

> Subject Device (Model: A65L) comparison with Predicate Device LEIPD4 and LDEPA2:

The same technological characteristics: A
- The Subject Device, Model: A65L has the same intended use, device design (Operational modes, Cooling System, Fiber optics, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Light intensity, Bur extraction force, Maximum air/water pressure, Speed in

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rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: LEIPD4.

In comparison to other Predicate Device Models, Model: LDEPA2, the Shaft materials of A65L are the same as the materials that LDEPA2 used in Sleeve that sleeve and shaft are the same as the hand-held parts of handpieces.
The difference technological characteristics: -
- . The only different device design between Subject Device, Model: A65L and Predicate Device, Model: LEIPD4 is the materials used in Shaft. The Shaft materials of A65L is Aluminum (Coating Materials: Aluminum (Anodizing) / Coating Range: Parts Appearance), but LEIPD4 is Brass (Coating Materials: Titanium / Coating Range: Parts Appearance).

A Subject Device (Model: A65) comparison with Predicate Device LEIPC4 and LDEPA2:

A The same technological characteristics:
- The Subject Device, Model: A65 has the same intended use, device design (Operational modes, Cooling System, Fiber optics, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Light intensity, Bur extraction force, Maximum air/water pressure, Speed in rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: LEIPC4.
- In comparison to other Predicate Device Models, Model: LDEPA2, the Shaft . materials of A65 are the same as the materials that LDEPA2 used in Sleeve that sleeve and shaft are the same as the hand-held parts of handpieces.
The difference technological characteristics: -
- The only different device design between the Subject Device, Model: A65 and Predicate Device, Model: LEIPC4 is the materials used in Shaft. The Shaft materials of A65 is Aluminum (Coating Materials: Aluminum (Anodizing) / Coating Range: Parts Appearance), but LEIPC4 is Brass (Coating Materials: Titanium / Coating Range: Parts Appearance).

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> Subject Device (Model: E-4010) comparison with Predicate Device LBIPA1, LBIPA1 and LEIPD4:

The same technological characteristics:
- The Subject Device, Model: E-4010 has the same intended use, device design (Operational modes, Cooling System, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Bur extraction force, Maximum air/water pressure, Speed in rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: LBIPA1.
- In comparison to other Predicate Device Models, Model: LDEPA2, the Shaft materials of E-4010 are the same as the materials that LDEPA2 used in Sleeve that sleeve and shaft are the same as the hand-held parts of handpieces.
The difference technological characteristics: -
- The Shaft materials of Subject Device, Model: E-4010 is Aluminum (Coating Materials: Aluminum (Anodizing) / Coating Range: Parts Appearance), but Predicate Device, Model: LBIPA1 is Brass (Coating Materials: Titanium / Coating Range: Parts Appearance).
- Subject Device, Model: E-4010 also has light function (fiber optics) that Predicate Device, Model: LBIPA1 hasn't, but in comparison to the other Predicate Device Model: LEIPD4, the device design of light function is the same as LEIPD4. The light function could make dentists see clearly in oral treatment working place.

A Subject Device (Model: E-4000) comparison with Predicate Device LBIPA1 and LDEPA2:

A The same technological characteristics:
- The Subject Device, Model: E-4000 has the same intended use, device design (Operational modes, Cooling System, Fiber optics, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Light intensity, Bur extraction force, Maximum air/water pressure, Speed in rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: LBIPA1.

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In comparison to other Predicate Device Models, Model: LDEPA2, the Shaft materials of E-4000 are the same as the materials that LDEPA2 used in Sleeve that sleeve and shaft are the same as the hand-held parts of handpieces.
The difference technological characteristics: -
- The only different device design between the Subject Device. Model: E-4000 and Predicate Device, Model: LBIPA1 is the materials used in Shaft. The Shaft materials of E-4000 is Aluminum (Coating Materials: Aluminum (Anodizing) / Coating Range: Parts Appearance), but LBIPA1 is Brass (Coating Materials: Titanium / Coating Range: Parts Appearance).

A Subject Device (Model: LEIPB1) comparison with Predicate Device LBIPA1 and LEIPD4:

A The same technological characteristics:
- The Subject Device, Model: LEIPB1 has the same intended use, device design (Operational modes, Cooling System, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Bur extraction force, Maximum air/water pressure, Speed in rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: LBIPA1.
- In comparison to other Predicate Device Models, Model: LDEPA2, the Shaft materials of LEIPB1 are the same as the materials that LDEPA2 used in Sleeve that sleeve and shaft are the same as the hand-held parts of handpieces.
The difference technological characteristics: -
- The only different device design between the Subject Device, Model: LEIPB1 and Predicate Device, Model: LBIPA1 is the materials used in Shaft. The Shaft materials of LEIPB1 is Aluminum (Coating Materials: Aluminum (Anodizing) / Coating Range: Parts Appearance), but LBIPA1 is Brass (Coating Materials: Titanium / Coating Range: Parts Appearance).
- Subject Device, Model: LEIPB1 also has light function (fiber optics) that Predicate Device, Model: LBIPA1 hasn't, but in comparison to the other Predicate Device Model: LEIPD4, the device design of light function is the same as LEIPD4. The light function could make dentists see clearly in oral

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treatment working place.

A Subject Device (Model: LEIPA1) comparison with Predicate Device LBIPA1 and LDEPA2:

-The same technological characteristics:
- The Subject Device, Model: LEIPA1 has the same intended use, device design (Operational modes, Cooling System, Fiber optics, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Light intensity, Bur extraction force, Maximum air/water pressure, Speed in rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: LBIPA1.
- In comparison to other Predicate Device Model: LDEPA2, the Shaft materials of LEIPA1 are the same as the materials that LDEPA2 used in Sleeve that sleeve and shaft are the same as the hand-held parts of handpieces.
The difference technological characteristics: -
- . The only different device design between the Subject Device, Model: LEIPA1 and Predicate Device, Model: LBIPA1 is the materials used in Shaft. The Shaft materials of LEIPA1 is Aluminum (Coating Materials: Aluminum (Anodizing) / Coating Range: Parts Appearance), but LBIPA1 is Brass (Coating Materials: Titanium / Coating Range: Parts Appearance).

> Subject Device (Model: A16C) comparison with Predicate Device AI4C:

-The same technological characteristics:
- The Subject Device, Model: AI6C has the same intended use, device design (Operational modes, Cooling System, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Light intensity, Bur extraction force, Maximum air/water pressure, Speed in rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: AI4C.
The difference technological characteristics: -

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The only one different device design between Subject Device, Model: AI6C and Predicate Device, Model: AI4C is the adding light function (fiber optics) of AI6C. The light function could make dentists see clearly in oral treatment working place.

A Subject Device (Model: AI2C) comparison with Predicate Device AI4C and AI2N:

-The same technological characteristics:
- The Subject Device, Model: AI2C has the same intended use, device design (Operational modes, Cooling System, Fiber optics, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Light intensity, Bur extraction force, Maximum air/water pressure, Speed in rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: AI4C.
- The hose connector's dimension of Subject Device, Model: AI2C is the same as the Predicate Device, Model: AI2N.
The difference technological characteristics: -
- The hose connector's dimension is different. The Subject Device, Model: AI2C is two holes design and the Predicate Device, Model: AI4C is four holes design. The choice of the holes of Air Motors are according to the dental units' hose connectors design and are not change the substantive functionality and safety in handpiece and air motor.

> Subject Device (Model: E-1110) comparison with Predicate Device AI4C:

A The same technological characteristics:
- The Subject Device, Model: E-1110 has the same intended use, device design (Operational modes, Cooling System, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Lubricant, Gear ratio are the same) as the Predicate Device, Model: AI4C.

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-The difference technological characteristics:
- The only different device design place between the Subject Device, Model: E-1110 and Predicate Device, Model: AI4C is the adding light function (fiber optics) of E-1110. The light function could make dentists see clearly in oral treatment working place.

A Subject Device (Model: E-1100) comparison with Predicate Device

The same technological characteristics: -
- . The Subject Device, Model: E-1100 has the same intended use, device design (Operational modes, Cooling System, Fiber optics, Dimensions, Type of chuck, Coupling dimensions, Accessories are the same) and technical specifications (Light intensity, Bur extraction force, Maximum air/water pressure, Speed in rpms, Bur Size, Lubricant, Gear ratio are the same) as the Predicate Device, Model: AI4C. This adding new model is for market segment purpose.
The difference technological characteristics: -
- . None.

7-8 Substantial Equivalent Devices :

The modified Codent Low Speed Dental Handpieces and Accessories have the following similarities to those which previous received 510(k) concurrence:

have the same indicated use,
use the same operating principle,
incorporate the same basic Codent Low Speed Dental Handpieces and Accessories design,
head of the Codent Low Speed Dental Handpieces incorporate the same materials,
sleeve of the Codent Low Speed Dental Handpieces incorporate the same materials,
shaft of the Codent Low Speed Dental Handpiece incorporate the same materials of Sleeve of the Codent Low Speed Dental Handpieces,
air Motor, the accessories of Low Speed Dental Handpieces, incorporate the same materials,
have the same shelf life, and ●
are packaged and sterilized using the same materials and processes.

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More comparative items are listed in Section of Substantial Equivalence Discussion, the tables and charts substantiate CODENT TECHNICAL INDUSTRY Co., Ltd's claim of the existence of predicate devices.

Intended Use
Proposed Device	Codent Low Speed Dental Handpieces and Accessories areintended for removing carious material, excess fillingmaterial, cavity and crown preparation, finishing toothpreparations and restorations, root canal preparations andpolishing teeth. The intended use is the same as inK133069.
Predicate Device(K133069)	Codent Low Speed Dental Handpieces and Accessories areintended for removing carious material, excess fillingmaterial, cavity and crown preparation, finishing toothpreparations and restorations, root canal preparations andpolishing teeth.
Models
Proposed Device	LEIPB1, LEIPA1, A61L, A61, A65L, A65, A11, E-2000,E-4010, E-4000, AI6C, AI2C, E-1110, E-1100.
Predicate Device(K133069)	LAISA1, LBIPA1, AI4C, AI2N, LAESA2, LDEPA2,AE4N, AE2N, LEIPD4, LEIPC4.

7-9 Non-Clinical Testing

7-9-1 Modify the Shaft materials of the Subject Device from Brass to Aluminum, but the Aluminum materials are used in the Sleeve of handpiece in Predicate Device

The Codent Low Speed Dental Handpieces and Accessories (K150798) use the same materials of Codent Low Speed Dental Handpieces and Accessories (K133069). We change of the Shaft materials of the Subject Device from Brass to Aluminum that are used in the Sleeve of handpiece in Predicate Device. Because the Aluminum could change the appearance color according to anodized process. The Alumium are used in the Sleeve of handpiece in Predicate Device which means there is no any concern regarding biocompatibility.

Risk assessment:

The materials of Codent Low Speed Dental Handpieces and Accessories (K150798) is the

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same as the Predicate Device, K133069. There is no any concern regarding biocompatibility risk.

7-9-2 Adding LED light function in Handpiece and Air Motor.

The fiber optic glass rod of Codent's dental handpiece is set a hard-clad fiber in handpiece's internal, and the hard-clad fiber is coated quartz glass fiber and made by high temperature vacuum sintering. Such production methods can make the lighting system smaller and avoid the fiber swing condition. The end of fiber optic glass rod in handpiece is connected to the LED lamp or halogen lamp light source of AI6C and E-1110, and the light source of AI6C and E-1110 projected light conducted by total internal reflection. Visible light can be efficiently transmitted through optical fibers and routed around corners and into inaccessible areas for lighting applications. Light emitted from the head of handpiece section which used in dental treatment. The fiber optic glass rod is located inside the handpiece and the design must consider the remaining space and angle of handpiece.

AI6C and E-1110 has two light sources, one is LED lamp and the other is Halogen lamp. The LED light source of AI6C and E-1110 is projected onto the end of handpiece, light source conduct through the fiber optic glass rod, then the head of handpiece reveal bright. And the light intensity of Codent's handpiece is at 27,000 lux maximum with LED lamp Air Motor and 20,000 lux maxmimum with halogen lamp Air Motor.

Risk assessment:

The LED lamp voltage is DC 3.8V, and the electric current is 20mA. The Halogen lamp voltage is DC 3.5V, and the electric current is 740mA that are a very small amount that does not cause high temperature risk,

7-9-3 Adding 2 holes design of Air Motor to comply with 2 holes dental unit needed.

The Subject Device, Model: AI2C hose connector's dimension is 2 holes design (drive air hole and spray water hole), but Predicate Device AI4C (K133069) hose connector's dimension is 4 holes design (drive air hole, exhaust air hole, spray air hole and spray water hole). In 2 holes design, the air comes from dental unit through the drive air hole of air motor into the head of handpiece, and dispersed two kinds of gas pipeline, one is for operating the turbine-driven and the other is to produce spray air to cause cooling mist. The remaining gas will be exhausted through the bottom of the handpiece. In 4 holes design, the drive air and spray air are dispersed two kinds of gas pipeline in air motor directly, and the

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remaining gas will be exhausted through the exhaust air hole of air motor into dental unit pipeline.

Risk assessment:

The dental unit has two holes or four holes connector design, and the purpose of operating the turbine-driven, produce spray air to cause cooling mist and exhaus the remaining gas are the same. The difference is only the pipeline route design, so there are not change the functionality and performance in handpiece and air motor. The change would not cause additional risk.

7-9-4 Functionality and Performance Test Results

We execute the bench testing about drop, noise, air supply, spray air supply, water supply, air and water pressure stability, temperature, vibrations, resistance to reprocessing, operating control, usability, chuck system for shanks, speed, eccentricity, torque and the experiment of illumination of the handpiece and air motor to detect whether the changes of design will cause any actual performance impact or not.

Risk assessment:

And the changes of design don't affect the functionality and performance test results that would not cause additional risk.

7-10 Conclusion:

After the risk assessment and analysis of performance bench testing data, it can be concluded that Codent Low Speed Dental Handpieces and Accessories is 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.