TRAUS SIP20 is an AC-powered device that includes a hand-held motor, contra angle handpiece and foot controller for regulation of speed and direction of rotation or a contra-angle attachment for dental surgery.

AI/ML Overview

This document describes a 510(k) premarket notification for a dental handpiece, the TRAUS SIP20. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove a device meets specific acceptance criteria through extensive clinical studies like those for novel AI devices or high-risk medical devices.

Therefore, the requested information regarding acceptance criteria, ground truth establishment, sample sizes for training/test sets, expert involvement, and MRMC studies, as typically applied to AI/ML clinical evaluations, is not present in this document. This submission primarily relies on comparing the new device's design and performance to an already cleared predicate device, demonstrating that any differences do not raise new questions of safety or effectiveness.

Here's how to address your request based on the provided document:

Overview of Device and Study Type

The TRAUS SIP20 is a dental handpiece for use in dental surgery and implantology. The "study" proving its performance is a substantial equivalence evaluation, primarily through non-clinical bench testing and comparison to predicate devices, rather than a clinical trial with acceptance criteria for diagnostic performance (e.g., sensitivity, specificity).

1. Table of Acceptance Criteria and Reported Device Performance

This type of comprehensive table with explicit acceptance criteria for diagnostic performance (e.g., accuracy, precision) is not applicable to this document as it's a 510(k) submission for a non-AI dental handpiece. The "performance" is demonstrated by showing equivalence in intended use, design, and adherence to safety standards.

Instead, the document highlights:

Feature/Test	Acceptance/Equivalence Claim	Reported Device Performance/Comparison
Intended Use/Indications for Use	Maintained substantial equivalence to predicate device.	TRAUS SIP20: "intended for use in dental surgery, implantology, for treatment of dental hard tissue and mechanical rotating root canal preparation." (Matches predicate TRAUS SIP10, with minor wording difference being "maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.")
Principle of Operation	Maintained substantial equivalence to predicate device.	"Dental handpiece is driven by electrical micromotor and internal gearings. The micromotor and internal gearings are controlled by a control box." (Identical to predicate)
Electrical Safety	Compliance with recognized medical electrical safety standards.	Tests performed according to: IEC 60601-1:2005 + A1:2012, IEC 80601-2-60:2012.
Electromagnetic Compatibility (EMC)	Compliance with recognized medical EMC standards.	Tests performed according to: IEC 60601-1-2:2014.
Software Validation (Firmware)	Software designed, developed, verified, and validated for "MODERATE level of concern".	Information provided in accordance with FDA guidance for software in medical devices.
Biocompatibility	Maintained substantial equivalence to predicate device.	Evaluated and cleared through previous FDA 510(k)s (K123695 & K182892) using "same materials and same manufacturing process." No design changes to relevant models. Device has "same type of patient contacting parts."
Sterilization	Maintained substantial equivalence for applied components.	Validation evaluated and cleared through previous FDA 510(k)s (K123695 & K182892) using "same materials and same manufacturing process." No design changes to relevant models (micromotors and handpieces).
Nonclinical Performance (Bench Test)	Performance demonstrated according to relevant standards.	Conducted according to ISO 14457:2017. Specific results (e.g., torque, speed, run-out) are not detailed in this summary but are implied to be acceptable for substantial equivalence.
Differences from Predicate (Control Box, New Handpieces)	Differences do not raise new questions of safety or effectiveness.	New control box specifications (Gear Ratio: SIP20 adds 1:2, 1:5, 32:1; removes 27:1, 64:1 from SIP10. Max. Irrigation Volume: SIP20 90ml/min ± 20%; SIP10 75ml/min). New angle handpieces (TRAUS CRB46LN and TRAUS CRB46NN) included, these are identical to FDA cleared components of a reference device (K182892). Safety and performance test reports supported these differences.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of clinical diagnostic performance. The "test set" for this device relates to the number of units or components tested during bench testing (e.g., for electrical safety, EMC, performance per ISO 14457). The specific sample size for these non-clinical tests is not detailed in the summary but would be part of the full submission.
Data Provenance: Not explicitly stated as "data" in the sense of patient images or outcomes. The data provenance would be the location where the safety and performance bench tests were conducted, likely within the manufacturer's R&D or a certified testing lab (e.g., in Republic of Korea).
Retrospective or Prospective: Not applicable. This is a non-clinical, bench-testing and design comparison submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This submission does not involve "ground truth" established by human experts for diagnostic purposes akin to image interpretation. The "truth" for this device is based on engineering specifications, adherence to standards, and physical performance measurements.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process described as this is not a diagnostic device relying on human interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was NOT done. This type of study is typically performed for AI-powered diagnostic tools to assess how AI assistance impacts human reader performance. This device is a mechanical dental handpiece, not an AI diagnostic tool.

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

Not applicable. This device is a mechanical tool. There is no "algorithm only" performance to evaluate in this context. While it has firmware (software with "MODERATE level of concern"), its "standalone performance" refers to its function as a controlled rotary instrument, evaluated through bench tests, not diagnostic accuracy.

7. The Type of Ground Truth Used

Not applicable in the common sense of diagnostic "ground truth" (e.g., pathology, clinical outcomes, expert consensus on images). The "ground truth" for this device's performance are engineering specifications, established international standards (e.g., ISO, IEC), and physical measurements from bench tests.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning, therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set exists for this device.

Summary

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February 11, 2021

Saeshin Precision Co., Ltd. % Dongha Lee Regulatory Affairs Consultant KMC, Inc. Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul. 08375 REPUBLIC OF KOREA

Re: K201292

Trade/Device Name: TRAUS SIP20 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EBW, EGS Dated: January 15, 2021 Received: January 26, 2021

Dear DongHa Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201292

Device Name TRAUS SIP20

Indications for Use (Describe)

TRAUS SIP20 is intended for use in dental surgery, implantology, for treatment of dental hard tissue and mechanial rotating root canal preparation.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary (K201292)

This summary of 510(K) - substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: February 10, 2021

1. Applicant / Submission Sponsor

Saeshin Precision Co., Ltd.

Address: #52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu 42921 Republic of Korea Fax : +82-53-580-0939 Tel : +82-53-587-2345

2. Submission Correspondent

DongHa Lee (Consultant, KMC, Inc.) Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, 08375, Korea Fax: +82-2-856-5904 Tel: +82-70-8965-5554 Email: dhlee@kmcerti.com

3. Device Identification

-Trade/Proprietary Name: TRAUS SIP20
-Classification Name: Dental handpiece and accessories
-Classification Regulation: 21CFR 872.4200
-Product Code: EBW, EGS
-Device Class: 1
-Review Panel: Dental

4. Primary Predicate Device

-K number: K123695
-Manufacturer: Saeshin Precision Co., Ltd.
-Trade Name: TRAUS SIP10

5. Reference Device

-K number: K182892
-Manufacturer: Saeshin Precision Co., Ltd.
-Trade Name: TRAUS Dental Handpieces

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Image /page/4/Picture/0 description: The image shows the logo for Saeshin. The logo consists of a blue geometric shape above the word "SAESHIN" in a stylized blue font. The geometric shape is made up of several smaller blue shapes, creating a three-dimensional effect. The word "SAESHIN" is written in all capital letters and has a futuristic, angular design.

4. Device Description

5. Indications for Use

TRAUS SIP20 is intended for use in dental surgery, implantology, for treatment of dental hard tissue and mechanical rotation.

6. Substantial Equivalence

The subject device, TRAUS SIP20 is derived from the primary predicate device, TRAUS SIP10.

Under the comparing substantial equivalence between the primary predicate device, there are the same points such as Product Code. Regulation number. Classification, Indications for use, and Principle of Operation. Besides, Micro motors (TRAUS MBP10SY and TRAUS MBPIOSL), Angle handpieces (TRAUS CRB26XX, TRAUS CRB27LX and TRAUS CRB27XX) and foot controller (TRAUS FUSIO) are identical to the primary predicate devices (TRAUS CRB46LN, TRAUS CRB46LN, TRAUS CRB46NN) for the subject device are identical to the reference device which is FDA cleared components (K182892).

Although there are some differences between the primary predicate device such as control box specification (gear ratio and maximum irrigation volume), nev angle handpieces (TRAUS CRB46NN), the safety and performance test reports are supported to the substantial equivalence. The differences do not raise different questions of safety and effectiveness.

Descriptive Information	Subject Device	Primary Predicate Device	Reference Device	Comparison
Manufacturer	Saeshin Precision Co., Ltd.	Saeshin Precision Co., Ltd.	Saeshin Precision Co., Ltd.	The same
Device Name	TRAUS SIP20	TRAUS SIP10	TRAUS Dental Handpieces	-
510(k) number	-	K123695	K182892	-
Classification Product Code /Regulatory Number	EBW, EGS / 872.4200	EBW, EGS / 872.4200	EGS / 872.4200	The same
Regulatory Class	1	1	1	The same
Indications for Use	TRAUS SIP20 is intendedfor use in dental surgery,implantology, fortreatment of dental hardtissue and mechanicalrotating root canalpreparation.	TRAUS SIP10 is intendedfor use in dental surgery,implantology, maxilla-facial surgery andendodontics for treatmentof dental hard tissue andmechanical rotating rootcanal preparation.	The TRAUS DentalHandpieces are indicatedfor wide range of dentalprocedures.A. Implant placement,including1. Preparation of theosteotomy site2. Bone contouring,osteoplastyB. Periodontal surgeries1. Bone contouring &alveoplasty around livingteeth2. Removal of exostosisC. Bone grafting1. Preparation of thedonor site (for e.g.symphysis and ascendingrames etc.)2. Harvesting autogenliving bone3. Sinus elevation &grafting of alveolarsocketsD. Removal andsectioning of teeth and	The same as the primary predicatedevice.
			impacted third molars andcomplicated extractions
Prescription or OTC	Prescription	Prescription	Prescription	The same
Principle of Operation	Dental handpiece is drivenby electrical micromotorand internal gearings. Themicromotor and internalgearings are controlled bya control box.	Dental handpiece is drivenby electrical micromotorand internal gearings. Themicromotor and internalgearings are controlled bya control box.	Dental Handpiece is geardriven hand-held dentalhandpieces. It can bedriven by torqueadjustable electricalmotors for surgerytreatment.	The same as the primary predicatedevice.
Components	Control box,Foot controller,Micro motor,Handpieces	Control box,Foot controller,Micro motor,Handpieces	Handpieces	The same as the primary predicatedevice.
Device Design - Control box
Model Name	TRAUS BIP20	TRAUS XIP10	-	-
Input Power	AC 100-120V, 50 / 60 Hz,48VA	AC 100-120V, 50 / 60 Hz,120W	N/A	Different
Gear Ratio	1:1, 1:2, 1:5, 16:1, 20:1,32:1	1:1, 16:1, 20:1, 27:1, 32:1,64:1	N/A	Different
LED Optic / Light Intensity	25,000 lux	25,000 lux		The same
Max. Irrigation Volume	Max. 90ml/min ± 20%	Max. 75ml/min		Different
Device Design - Foot controller
Model Name	TRAUS FUS10	TRAUS FUS10	N/A	Same component as the primarypredicate device
Degree of protection againstingress of water (IEC 60529)	IPX8	IPX8	N/A
Device Design - Micro motor
Model Name	TRAUS MBP10SX,TRAUS MBP10SL	TRAUS MBP10SX,TRAUS MBP10SL
Fiber optics	N/A	N/A		Same components as the primarypredicate device
Motor Type	BLDC	BLDC	N/A
RPM	40,000 rpm	40,000 rpm
Fiber optics	Only for TRAUSMBP10SL	Only for TRAUSMBP10SL
Device Design - Angle Handpiece
Model Name	TRAUS CRB26LX,TRAUS CRB26XX,TRAUS CRB27LX,TRAUS CRB27XX,TRAUS CRB46LN,TRAUS CRB46NN	TRAUS CRB26LX,TRAUS CRB26XX,TRAUS CRB27LX,TRAUS CRB27XX,	TRAUS CRB46LNTRAUS CRB46NN
Fiber optics	Only forTRAUS CRB26LX,TRAUS CRB27LX,	Only forTRAUS CRB26LX,TRAUS CRB27LX	Only forTRAUS CRB46LN,	Same components as the primarypredicate device or the reference
Rear Ratio	20:1(TRAUS CRB26LX,TRAUS CRB26XX)32:1(TRAUS CRB27LX,TRAUS CRB27XX)20:1(TRAUS CRB46LN,TRAUS CRB46NN)	20:1(TRAUS CRB26LX,TRAUS CRB26XX)32:1(TRAUS CRB27LX,TRAUS CRB27XX)	20:1(TRAUS CRB46LN,TRAUS CRB46NN)	device

Speed in rpm	Max. 2,000 rpm(TRAUS CRB26LX,TRAUS CRB26XX)Max. 1,250 rpm(TRAUS CRB27LX,TRAUS CRB27XX)Max. 2,000 rpm(TRAUS CRB46LN,TRAUS CRB46NN)	Max. 2,000 rpm(TRAUS CRB26LX,TRAUS CRB26XX)Max. 1,250 rpm(TRAUS CRB27LX,TRAUS CRB27XX)	Max. 2,000 rpm(TRAUS CRB46LN,TRAUS CRB46NN)
Material (in contact with patient)	SUS 303FSUS 420F	SUS303FSUS 420F	SUS303FSUS 420F
Chuck Design	For Shank Type 1 by ISO 1797	For Shank Type 1 by ISO 1797-1	For Shank Type 1 by ISO 1797-1
Bur Extraction Force	45 N	45 N	45 N
Conformance with standards for shanks	Shank Type: Type 1 by ISO 1797	Shank Type: Type 1 by ISO 1797-1	Shank Type: Type 1 by ISO 1797
Coupling dimensions for micro motor	ISO 3964	ISO 3964	ISO 3964

The following comparison table is presented to demonstrate substantial equivalence.

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Image /page/6/Picture/0 description: The image contains the logo for SAESHIN. The logo consists of a blue geometric shape above the word "SAESHIN" in a stylized, sans-serif font. The geometric shape is made up of several smaller blue triangles arranged to form a larger, three-dimensional shape.

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Image /page/7/Picture/0 description: The image contains the logo for SAESHIN. The logo consists of a geometric shape resembling a stylized letter "S" above the word "SAESHIN" in a stylized font. The geometric shape is made up of several blue diamond shapes, and the word "SAESHIN" is in a blue, sans-serif font.

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Image /page/8/Picture/0 description: The image features the logo for SAESHIN. The logo consists of a geometric shape above the company name. The geometric shape is a blue hexagon made up of smaller blue triangles. The company name, "SAESHIN", is written in a stylized blue font below the geometric shape.

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Image /page/9/Picture/0 description: The image shows the logo for SAESHIN. The logo consists of a blue geometric shape above the company name. The geometric shape is made up of several smaller squares and triangles, arranged to form a larger cube-like structure. The company name, "SAESHIN," is written in a stylized, sans-serif font in blue.

7. Electrical Safety and Electromagnetic Compatibility

The Electrical Safety and Electromagnetic Compatibility tests were performed in accordance with the following standards.

IEC 60601-1:2005 + A1:2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-IEC 80601-2-60:2012, Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
IEC 60601-1-2:2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

8. Software Validation:

TRAUS SIP20 contains MODERATE level of concern software (firmware). The software was designed and developed according to a software development process and was verified and validated.

Software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices.

9. Biocompatibility

The handpiece has been completely evaluated and cleared through the previous FDA 510K (K123695 and K182892) as the same materials and the same manufacturing process as the company's own devices. (There have been no design changes in any of these models.)

In comparing the biocompatibility of the device with the primary predicate device and reference device, it is demonstrated that the device has the same type of patient contacting parts, which are classified the same concerning body contact and contact duration.

Based on the above evaluation, the dental handpieces are substantially equivalent to the primary predicate devices in terms of biocompatibility.

10. Sterilization

The sterilization validation of the applied components (Micro motor cap, Angle Handpiece) has been completely evaluated and cleared through the previous FDA 510K (K123695 and K182892) as the same materials and the same manufacturing process as the company's own devices. (There have been no design changes in any of these models (micromotors and handpieces))

11. Nonclinical Performance Test - Bench Test

The performance tests were conducted as bench test according to ISO 14457: 2017.

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Image /page/10/Picture/0 description: The image contains the logo for Saeshin. The logo consists of a geometric shape above the word "SAESHIN" in blue, block letters. The geometric shape is a stylized, three-dimensional hexagon composed of smaller blue triangles, creating a sense of depth and complexity.

12. Clinical Testing

No clinical study was considered necessary and performed.

13. Conclusion

Under the comparing substantial equivalence between the subject device and the predicate device, there are the same points such as Product Code, Regulation number, Classification, Indications for use, and Principle of Operation. Besides, Micro motors (TRAUS MBP10SX and TRAUS MBP10SL), Angle handpieces (TRAUS CRB26LX, TRAUS CRB26XX, TRAUS CRB27LX and TRAUS CRB27XX) and foot controller (TRAUS FUS10) are identical to the predicate device. The newly added angle handpieces (TRAUS CRB46LN, TRAUS CRB46NN) for the subject device are identical to the reference device which is FDA cleared components (K182892).

Although there are some differences between the subject device and the predicate device such as control box specification (gear ratio and maximum irrigation volume), new angle handpieces (TRAUS CRB46LN and TRAUS CRB46NN), the safety and performance test reports are supported to substantial equivalence. The differences do not raise different questions of safety and effectiveness.

In this regard, we conclude that the subject device is substantially equivalent to the predicate device.

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.