Dental Handpiece with models of CA160, and CA500L are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Device Description

Dental Handpiece with the model CA160, CA160L and CA500L consists of the main body of the handpiece, which is used for transmitting rotational force for the general dental treatments. The torque transmitted from a wired electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.

Model CA160, CA160L and CA500L can be connected to spray adapter (accessory component) which is used for channeling water and air for further applications to the dental treatments. The only difference between model CA160 and CA160L is that the CA160L has lighting function.

AI/ML Overview

The provided text is a 510(k) summary for a dental handpiece. It details the device's equivalence to a predicate device but does not describe an AI medical device or a study involving AI performance metrics like sensitivity, specificity, or reader studies. Instead, it focuses on the engineering and biocompatibility testing of a physical dental instrument.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance for an AI model, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the content provided.

The document discusses the following types of tests for the dental handpiece:

Design Verification & Performance Data:

Appearance Test
Operation Test
Rotational Speed Test
Noise Test
Spray Test
Light Test
Serviceable Year/Shelf-Life Test

Biocompatibility Testing (applicable from the predicate device):

ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP)
ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts)
ISO Intracutaneous Irritation Test (GLP 2 Extracts)
ISO Materials Mediated Rabbit Pyrogen (GLP)
ISO Acute Systemic Injection Test (GLP 2 Extracts)

The document concludes that the proposed device is substantially equivalent to the predicate device based on these tests and that no new questions of safety or effectiveness are raised.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 29, 2022

Micro-NX Co., Ltd. % Seohee Kwon RA Manager K-Bio Solutions 201 South 4th Street, Suite 727 San Jose. California 95112

Re: K220577

Trade/Device Name: Dental Handpiece, Model CA160, CA160L, and CA500L Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EGS Dated: May 10, 2022 Received: May 17, 2022

Dear Seohee Kwon:

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 and ENT 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) K220577

Device Name Dental Handpiece

Indications for Use (Describe)

The Dental Handpiece with models of CA160, and CA500L are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K220577

Pursuant to Section 510(k) of Chapter V of the Federal Food, Drug, and Cosmetic Act and in accordance with subpart E of Part 807, Title 21 of the Code of Federal Regulations, MICRO-NX Co., Ltd. submits the following information as premarket notification for the proposed device, Dental Handpiece with models of CA160, CA160L, and CA500L.

I. SUBMITTER

510(k) Correspondent: Seohee Kwon RA Specialist, K-Bio Solutions (seohee.kwon(@kbiotechsolutions.com) Tel: 82-2-597-2700

Sponsor: MICRO-NX Co., Ltd. 22 Maeyeo-ro 1 gil, Dong-gu, Daegu Postal code: 41059, Republic of Korea Tel: 82-053-650-1000 Fax: 82-053-650-1005

Manufacturer Contact: Sojeong Park (sojeong(@micronx.co.kr) Date Prepared: May 10th, 2022

II. SUBMISSION DEVICE

Trade Name: Dental Handpiece ●
Common Name: Handpiece, dental ●
Classification Name: Dental handpiece and accessories ●
Regulation Number: 21 CFR 872.4200 ●
Regulation Name: Dental handpiece and accessories ●
Product Code: EGS ●
Review Panel: Dental ●
Regulatory Class: Class I ●
Traditional 510(k) Registration .

Prior formal correspondence with the FDA resulted in the 510(k) clearance of the Micro-NX Dental Handpiece(K192809) with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R.

III. PREDICATE DEVICES

Predicate Device: Dental Handpiece (K192809), Manufacturer: Micro-NX Co., Ltd.

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IV. DEVICE DESCRIPTION

The intended use of the Dental Handpiece with models of CA160L, and CA500L are the same as the intended use of the predicate (K192809), model CA 100L and CA100R.

Dental Handpiece with models of CA160, CA160L, and CA500L are intended for the . removal of carious material. reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
Predicate Dental Handpiece (K192809) with models of CA100L and CA100R are ● intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Model CA160, CA160L and CA500L

All components of the Model CA160, CA160L and CA500L are the same as the predicate model CA100L and CA100R (K192809) with containing the main body and spray adapter. Model CA160, CA160L and CA500L can be connected to spray adapter (accessory component) which is used for channeling water and air for further applications to the dental treatments. The only difference between model CA160 and CA160L is that the CA160L has lighting function.

The component allocations of the proposed models of Dental Handpiece are provided in Table IV-1 below.

Table IV-1 Proposed device Model and Component Specificat
Model	CA160	CA160L	CA500L
Main Body	X	X	X
Spray Adapter	X	X	X

Table IV-1 Proposed device Model and Component Specification

The four product codes and models of Dental Handpiece are CA160, CA160L, and CA500L. The component names and functional descriptions for critical components of Dental Handpiece are provided in Table IV-2below.

Table IV-2. Component Names and Functional Descriptions for Critical Components of Dental Handpiece: CA160, CA160L, CA500L

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Component Name	Function
Components of Handpiece Model CA500L
Spindle Assembly	Receives torque from Middle Gear Assembly and transmits torque to final dental bur
Middle Gear Assembly	Transmitting the rotational force from the Inner Handle Assembly and delivers the rotational force to the Spindle Assembly
Button Assembly	Button for removal and attachment of the hand piece head
Head Cap	Case that wraps the Spindle Assembly. Head Cap is assembled with Button Assembly and Middle Gear Assembly
Head Assembly	The component that is assembled Spindle Assembly, Middle Gear Assembly, Button Assembly, Head Assembly
Joint Gear Assembly	Transmits the torque received from the motor to the Head Assembly
Inner Handle	Case to fix Joint Assembly
Optic	Optical fiber that allows light to pass from the motor's LED light source to the handpiece head
Irrigation Pipe Assembly	Pipes for water supply
Angle Handle A	The case of Middle Bevel Gear, Optic, Irrigation Pipe
Angle Handle Assembly	The case of Joint Gear Assembly, Optic, Head
Component Name	Function
Common Components of Handpiece Model CA160 and CA160L
Spindle Assembly	Receives torque from Middle Gear Assembly and transmits torque to final dental bur
Middle Gear Assembly	Transmitting the rotational force from the Inner Handle Assembly and delivers the rotational force to the Spindle Assembly
Button Assembly	Button for removal and attachment of the hand piece head
Head Cap	Case that wraps the Spindle Assembly. Head Cap is assembled with Button Assembly and Middle Gear Assembly
Head Assembly	The component that is assembled Spindle Assembly, Middle Gear Assembly, Button Assembly, Head Assembly

Gear BoxAssembly	It consists of several gears and decelerates.
Joint GearAssembly	Transmits the torque received from the motor to the Head Assembly
Inner Handle	Case to fix Joint Assembly
LockingHandle	Head assembly's attachment and detachment.
Angle HandleAssembly	The case of Joint Gear Assembly, Optic, Head
Components only Available for Handpiece Model CA160
Angle Body	The case is installed in Handle Assembly
Components only Available for Handpiece Model CA160L
Optic	Optical fiber that allows light to pass from the motor's LED light source tothe handpiece head
Angle Body	The case is installed in Handle Assembly and protect the optics.

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V. INDICATIONS FOR USE/INTENDED USE

Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Fundamental technological characteristics of MICRO-NX Dental Handpiece models CA160, and CA500L are substantially equivalent to the predicate device, MICRO-NX Dental Handpiece(K192809) as demonstrated in Table VI-1 belov.

Proposed Device:	Predicate Device:	Substantial Equivalence Assessments
Dental Handpiece with modelsCA160, CA160L, andCA500L	Dental Handpiece (MICRO-NX, K192809)
Intended Use /Indications forUse	Dental Handpiece with modelsof SG200, SG200L, SA100L,SA100R, CA100L, andCA100R are intended for theremoval of carious material,reducing of hard toothstructure, cavity and crownpreparations, root canalpreparations, removal offillings, processing andfinishing tooth preparations,and restorations for polishingteeth.In addition, Dental Handpiecewith models of SG200,SG200L are also intended for	Intended use and indications foruse are the same between DentalHandpiece with models ofCA160, CA160L, and CA500Land the predicate device DentalHandpiece (MICRO-NX,K192809) for the removal ofcarious material, reducing of hartooth structure, cavity and crowrpreparations, root canalpreparations, removal of fillings,processing and finishing toothpreparations, and restorations forpolishing teeth. Dental Handpiecis designed for use by a trainedprofessional in the field of generdentistry.
Dental Handpiece with modelsof CA160, CA160L, andCA500L are intended for theremoval of carious material,reducing of hard toothstructure, cavity and crownpreparations, root canalpreparations, removal offillings, processing andfinishing tooth preparations,and restorations for polishingteeth.Dental Handpiece is designedfor use by a trainedprofessional in the field ofgeneral dentistry.
		implant surgery such asperforating the bone, tappingandthreading procedures.Dental Handpiece is designedfor use by a trainedprofessional in the field ofgeneral dentistry.	Compared to the proposed DentalHandpiece models of CA160,CA160L, and CA500L, theintended use/indications for use ofthe predicate for SG200 andSG200L model (K192809) haveadditional intendeduse/indications for use for implantsurgery such as perforating thebone, tapping and threadingprocedures. This particular,additional indications are notapplicable to the proposed DentalHandpiece models of CA160,CA160L, and CA500L.The predicate (K192809) modelsof SG200 and SG200L are notsubject of the substantialequivalence comparison with theproposed Dental Handpiece. Onlythe predicate models of CA100Land CA100R (K192809), whichdo not contain the additionalintended use/indications for useare subject for substantialequivalence comparison with theproposed Dental Handpiecemodels CA160, CA160L, andCA500L.
FunctionalPrinciple	Dental Handpiece with modelsof CA160, CA160L, CA500L:Through the micro motorconnected to the dental	Through the micro motorconnected to the dentaltreatment unit, the straight andcontra-angle handpieces	Similar Functional Principle
	treatment unit, the contra-angle handpieces equippedwith a handpiece connectionaccording to ISO 3964(Dentistry - Couplingdimensions for handpiececonnectors - ISO 3964:1982)receive the energy, the coolingwater and air for treatment andthe light for illumination theoperating area.	equipped with a handpiececonnection according to ISO3964 (Dentistry - Couplingdimensions for handpiececonnectors - ISO 3964:1982)receive the energy, the coolingwater and air for treatment andthe light for illumination theoperating area.
Dimensions	CA160, CA160L, CA500LHead size-Length: Up to15mmHead size-Diameter: Up to9mmLength: Up to 95mm	Head size-Length: Up to14mmHead size-Diameter: Up to9mmLength: Up to 95.80mm	The head size, height, anddiameter of Dental Handpiece arebroadly in alignment with thedimensions of the predicate,Dental Handpiece (MICRO-NX,K192809). The minute differencesin the identified dimensions donot raise different questions interms of safety and effectiveness.
Direct patient-contactingportions of thedevice	All materials for DentalHandpiece models are listed inthe raw material table aboveincluding chemicalcomposition of the waterlinesand the patient-contactingportions of the device.Biocompatible according toISO 10993-1 (Biologicalevaluation of medical devices -Part 1: Evaluation and testingwithin a risk managementsystem - ISO 10993-1:2009)	All materials for DentalHandpiece models are listed inthe raw material table aboveincluding chemicalcomposition of the waterlinesand the patient-contactingportions of the device.Biocompatible according toISO 10993-1 (Biologicalevaluation of medical devices -Part 1: Evaluation and testingwithin a risk managementsystem - ISO 10993-1:2009)	The proposed Dental Handpiecemodels CA160, CA160L, andCA500L are additional models tothe predicate device of DentalHandpiece (MICRO-NX,K192809) and have identicalpatient contacting materials to thepredicate device. Therefore,predicate device biocompatibilitytest result per the standards of ISO10993-1 is applicable to themodels of the proposed device.
Indirectpatient- contactingportions of thedevice (water /air lines)	All materials for DentalHandpiece models are listed inthe tables above includingchemical composition of thewaterlines and the patient- contacting portions of thedevice. Biocompatibleaccording to ISO 10993-1(Biological evaluation ofmedical devices - Part 1:Evaluation and testing within arisk management system - ISO10993-1:2009)	All materials for DentalHandpiece models are listed inthe tables above includingchemical composition of thewaterlines and the patient- contacting portions of thedevice. Biocompatibleaccording to ISO 10993-1(Biological evaluation ofmedical devices - Part 1:Evaluation and testing within arisk management system - ISO10993-1:2009)	The proposed Dental Handpiecemodels CA160, CA160L, andCA500L are additional models tothe predicate device of DentalHandpiece (MICRO-NX,K192809) and have identical in- direct patient contacting materialsto the predicate device.Therefore, predicate devicebiocompatibility test result per thestandards of ISO 10993-1 isapplicable to the models of theproposed device.
Chuck Design	Push Button	Push Button, Latch Type	Same,Chuck design of the proposedDental Handpiece is push buttontype, whereas the predicatedevice(K192809) has additionalchuck design type of latch type.
Motor SpeedRange(RPM's)	Up to 40,000 rpm	Up to 40,000 rpm	Similar Speed Range
ConformanceStandards(Handpiecesand Motors)	ISO 14457 (Dentistry -Handpieces and motors - ISO14457:2012)	ISO 14457 (Dentistry -Handpieces and motors - ISO14457:2012)	Compliant with the samestandards for dentistry handpieceand motors.
ConformanceStandards(Shanks)	ISO 1797 (2017) “Dentistry -Shanks for rotary andoscillating instruments”	ISO 1797 (2017) “Dentistry -Shanks for rotary andoscillating instruments”	Compliant with the samestandards of dentistry shanks.
ConformanceStandards(CouplingDimensions)	ISO 3964 (Dentistry -Coupling dimensions forhandpiece connectors - ISO3964:1982)	ISO 3964 (Dentistry -Coupling dimensions forhandpiece connectors - ISO3964:1982)	Compliant with the samestandards ofISO 3964 (Dentistry - Couplingdimensions for handpiececonnectors - ISO 3964:1982)
Sterilization	Sterilizable according to ISO17665-1 (Sterilization ofhealth care products – Moistheat - Part 1: Requirements forthe development, validationand routine control of asterilization process formedical devices on the final,finished device - ISO176651:2006)	Sterilizable according to ISO17665-1 (Sterilization ofhealth care products – Moistheat - Part 1: Requirements forthe development, validationand routine control of asterilization process formedical devices on the final,finished device - ISO176651:2006)	Conform to the same standardsfor user sterilization.
Air / waterports	Internal Spray	Internal/ External Spray	Same,Compared to the predicatedevice(K192809) which consistsof internal and external spraycomponents, the proposed DentalHandpiece only consists ofinternal spray.
GearRatio	CA160, CA160L: 16:1CA500L: 1:5	20:1/ 1:1	Compared to the predicate deviceof Dental Handpiece (MICRO-NX, K192809), the addition of agear ratio of 1:5 and 16:1 does notraise different questions in termsof safety and effectiveness giventhe favorable test results ofperformance testing of DentalHandpiece.

Table VI-1. Substantial Equivalence Assessment between MICRO-NX Dental Handpiece and Predicate Device(K192809)

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Overall, Design verification testing were performed to assess the following critical devices used in dentistry applications. The favorable test results of the proposed device which confirmed to meet the FDA recognized standards as well as ISO

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standard demonstrate Dental Handpiece retains the substantially equivalent profile in safety and essential performance of medical electrical equipment as the predicate device Dental Handpiece (MICRO-NX, K192809).

· ISO 3964 (2016) "Dental Handpieces Coupling dimensions" (Recognition List Number: 003 Effective Date: 05/03/1999)
· ISO 14457 (2017) "Dentistry Handpieces and motors" (Recognition List Number: 031 Effective Date: 09/15/2012)
· ISO 1797 (2017) "Dentistry Shanks for rotary and oscillating instrument

VII. DESIGN VERIFICATION & PERFORMANCE DATA

The following design vertification and performance data are provided in support of the conclusive determination that the proposed dental handpiece is substantially equivalent to the predicate device Dental Handpiece (MICRO-NX, K 1192809).

Biocompatibility Testing

The biocompatibility testing conducted for the predicate device (K192809) is applicable to the proposed Dental Handpiece models CA160, CA160L. The proposed Dental Handpiece models CA160, CA160L, and CA500L are additional models to the predicate device Dental Handpiece (K192809). All of the patient-contacting raw materials of the proposed Dental Handpiece models are the predicate device Dental Handpiece (K192809) with no new introduction of patient contacting raw materials for the proposed Dental Handpiece models.

In accordance with ISO 10993-1: 2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the Dental Handpiece models CA160L, and CA500L is classified as "Externally Communicating Device-Tissue/dentin (Limited contact duration). This is the same classification of the biocompatibility evaluation as the predicate Dental Handpiece (K192809).

The biocompatibility testing of the Dental Handpiece listed below has been conducted in 2019 in order to ensure FDA's latest consensus standards with respect to biocompatibility evaluations are met for the favorable biocompatibility test results drawn in 2019 testing confirms the biocompatibility profile of the Dental Handpiece.

ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP) .
ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts) ●
ISO Intracutaneous Irritation Test (GLP 2 Extracts) ●
ISO Materials Mediated Rabbit Pyrogen (GLP) .

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ISO Acute Systemic Injection Test (GLP 2 Extracts) .

Design Verification and Validation Testing

The proposed, Micro-NX Dental Handpiece models CA160L, and CA500L have been evaluated and risk management practice has been implemented in accordance with ISO 14971 Medical devices - applications of risk management to medical devices.

Appearance Test .
Operation Test .
Rotational Speed Test ●
Noise Test ●
Spray Test ●
Light Test .
Serviceable Year/ Shelf-Life Test ●

The favorable results of the design verification testing demonstrate the design output of Dental Handpice conform to the applicable, pre-determined design requirements of the Dental Handpiece. The testing results also further demonstrate the proposed Dental Handpiece models are substantially equivate device (K192809), as the proposed and predicate device are subject to the same applicable test standards of design requirements for dental handpiece.

Therefore, the identified differences in terms of the dimensions and outer appearance between the proposed Dental Handpiece models CA160, CA160L, and CA500L and the predicate (K192809) CA100L and CA100R do not raise different questions in safety and effectiveness compared to the predicate device Dental Handpiece (K192809).

VIII. CONCLUSIONS

Overall, the proposed device is comparable to the predicate device given the fact that its indications for use are the same, and fundamental technological characteristics are equivalent to those of the predicate device Dental Handpiece (MICRO-NX, K192809). The favorable results of the aforementioned design verfication and performance to the appropriate standards perinent to dental handpieces, and demonstrate that no different questions of safety and effectiveness assessment are being raised compared to the predicate device of Dental Handpiece (MICRO-NX, K192809).

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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.