(581 days)
The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points. When connected to Apex locator (EQ-PEX), the EQ-M can be used to measure the length of root canals.
EQ-M is micro motor needed to make canal enlargement for root canal treatment. The battery in the motor handpiece is used as a power source and the rotational power generated by rotating the micro motor is transmitted to the crown gear of the angle head through the bevel gear and shaft. The resulting rotational power is transmitted to the file to rotate the file. When connected to Apex Locator (EQ-PEX), the EQ-M indicates the position of the file tip inside the root canal.
The EQ-PEX is Electronic Apex Locator and accessories to be used to treat patients. It consists of the main body and lip hook, probe cord. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies.
The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.
The document provided is a 510(k) summary for a dental device, EQ-M, and does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/ML-based device evaluation.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and performance properties, rather than establishing and testing against specific acceptance criteria for AI/ML performance.
Therefore, I cannot provide the requested table and study information based on the given text.
Specifically, the document lacks information on:
- Acceptance criteria and reported device performance (for AI/ML): There are no specific quantitative acceptance criteria or corresponding reported performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML component. The "Performance 2 - apex locator" listed refers to the accuracy of the root apex locator function, which is a hardware/software integration feature, not an AI/ML performance metric.
- Sample size for the test set and data provenance: No information is provided about a test set for evaluating an AI/ML component.
- Number of experts and qualifications for ground truth: No mention of experts establishing ground truth for evaluating an AI/ML component.
- Adjudication method: Not applicable as there's no AI/ML test set adjudication described.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned or implied.
- Standalone (algorithm only) performance: No standalone performance of an AI/ML algorithm is described.
- Type of ground truth used: Not applicable as there's no AI/ML component evaluation described.
- Sample size for the training set: Not applicable as there's no AI/ML component described.
- How ground truth for the training set was established: Not applicable as there's no AI/ML component described.
The non-clinical studies mentioned are related to electrical safety, electromagnetic compatibility, usability, software lifecycle, battery safety, and biocompatibility, which are standard for medical device approvals, but do not pertain to the performance evaluation of an AI/ML system.
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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 & 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.
September 21, 2022
Meta Systems Co., Ltd % Yang Ho Dong Manager Onbix Corporation #821 Samil Plaza, 14 Dogok-ro 1-gil, Gangnam-gu Seoul, 06253 SOUTH KOREA
Re: K210475
Trade/Device Name: EQ-M Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX, LQY Dated: August 16, 2022 Received: August 23, 2022
Dear Yang Ho Dong:
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.
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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 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 mediation-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210475
Device Name EQ-M
Indications for Use (Describe)
The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points. When connected to Apex locator (EQ-PEX), the EQ-M can be used to measure the length of root canals.
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 K210475
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR ઠુક્ષ્ઠ07.92.
| Submitter Information: | Meta Systems Co., Ltd#1214-18, Sicox tower 12F, 484, Dunchon-daero,Jungwon-gu, Seongnam-si, Gyeonggi-do, 13229, KoreaTel. +82-31-731-7377 |
|---|---|
| Contact Person: | Ho Dong, YangOnbix Corporation#821 Samil Plaza, 14 Dogokro 1-gilGangnam-gu, Seoul, Korea (06253)Tel: *82-2-566-3360 / Fax: *82-2-6280-3360Email: onbix@naver.com |
| Date Summary Prepared: | Sep 16, 2022 |
| Device Information: | |
| Trade Name(s): | EQ-M |
| Common/Usual Name: | Dental Endo Motor |
| Classification Name: | handpiece, direct drive, ac-powered |
| Regulation Class: | Class 1 |
| Panel: | Dental |
| Regulation Number: | 872.4200 |
| Primary Product Code: | FKX |
Predicate Device Information:
Additional Product Code:
| K number | Device name | Manufacturer | |
|---|---|---|---|
| Primary PredicateDevice | K112665 | Tri Auto mini | J. MORITA MFG.CORP |
| Reference Device | K170275 | Tri Auto ZX2 | J. MORITA MFG.CORP |
LQY
Device Description:
EQ-M is micro motor needed to make canal enlargement for root canal treatment. The battery in the motor handpiece is used as a power source and the rotational power generated by rotating the micro motor is transmitted to the crown gear of the angle head through the bevel gear and shaft. The resulting rotational power is transmitted to the file to rotate the file. When connected to Apex Locator (EQ-PEX), the EQ-M indicates the position of the file tip inside the root canal.
The EQ-PEX is Electronic Apex Locator and accessories to be used to treat patients. It consists of the main body and lip hook, probe cord. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies.
The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.
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Indications for Use:
The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove guttapercha points. When connected to Apex locator (EQ-PEX), the EQ-M can be used to measure the length of root canals.
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in its intended use and technological characteristics, including:
-
- indications for use
-
- technological characteristics
-
- performance properties
Summary of the technological characteristics compared to the predicate device
Subject device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table as attached.
Comparison of Technical characteristics
| Features | Subject Device | PrimaryPredicate Device | Reference Device | Comparison | |
|---|---|---|---|---|---|
| Product name | EQ-M | Tri Auto mini | Tri Auto ZX2 | - | |
| 510(k) number | - | K112665 | K170275 | - | |
| Applicant | Meta Systems Co.,Ltd. | J. MORITA MFG.CORP. | J. MORITA MFG.CORP. | - | |
| PrimaryProduct Code | EKX | EKX | EKX | Same. | |
| AdditionalProduct Code | LQY | - | LQY | Same | |
| Components | Handpiece, Contraangle, Battery,Battery charger,Power Cord,AC/DC Adapter | Handpiece, Contraangle, Battery,Battery charger,Power Supply Cord | Handpiece, Contraangle, BatteryCharger, ACAdapter, ContraryElectrode, FileHolder, Probe Cord | Same | |
| Operation withApex Locator | 1. Connect Contraangle2. File installation3. Connect thehandpiece to theApex Locator with aTransmission cable(probe cord).4. Themeasurement barshows the locationof the file tip.5. Hook theContrary Electrode(Lip hook) in thecorner of thepatient's mouth.6. Operate thehandpiece.7. If the file tip goespast the Flash bar, | 1. Connect Contraangle2. File installation3. Connect thehandpiece to theApex Locator with aTransmissioncable.4. Themeasurement barshows the locationof the file tip.5. Hook theContrary Electrodein the corner of thepatient's mouth.6. Operate thehandpiece.7. If the file tip goespast the Flash bar,an alarm will sound | 1. Connect Contraangle2. File installation3. Connect theprobe cord to themotor handpiece.4. Connect the fileholder and the liphook to the probecord respectively.5. Themeasurement barshows the locationof the file tip.6. Hook theContrary Electrodein the corner of thepatient's mouth.7. Operate thehandpiece.8. If the file tip goes | Same | |
| an alarm will soundand the backlightwill blink on an off. | and the backlightwill blink on an off. | past the Flash bar,an alarm will soundand the backlightwill blink on an off. | |||
| ComparisonStatement | The EQ-Mmotorizedhandpiece can beused to enlargeand prepare rootcanals, removegutta-perchapoints.When connected toApex locator, theEQ-M can be usedto measure thelength of rootcanals. | The Tri Auto minimotorizedhandpiece can beused to enlargeand prepare rootcanals, removegutta-perchapoints, and forprofessional toothcleaning. Whenconnected to Apexlocator, the Tri Automini can be used tomeasure the lengthof root canals. | The Tri Auto ZX2device is a cordlessendodontictreatmentmotorizedhandpiece with rootcanal measurementcapability. It can beused to enlargecanals whilemonitoring theposition of the filetip inside the canal.It can be used as alow-speedmotorizedhandpiece anddevice formeasuring canallength. | Same | |
| Principle ofoperation | The battery in themotor handpiece isused as a powersource and therotational powergenerated byrotating the micromotor is transmittedto the crown gearof the angle headthrough the bevelgear and shaft. Theresulting rotationalpower istransmitted to thefile (tip) to rotatethe file (tip). Whenconnected to ApexLocator (EQ-PEX),the EQ-M indicatesthe position of thefile tip inside theroot canal. | The Tri Auto mini isa Battery- drivenhandpiece with amotor, equippedwith the chuck forholding rotaryinstrument such asa dental file and areamer. Tri Automini can be usedfor enlargementand preparation ofroot canals. Whenconnected to ApexLocator, the TriAuto mini indicatesthe position of thefile tip inside theroot canal. | Electrical motordrives the rotatingof file equipped onthe rotating toaccomplish itsindication for use.And the softwarecontrol theparameter andmethod of rotating. | Same | |
| Intended use | - Canalenlargement- Root canal lengthmeasurement(When connectedto Apex Locator) | - Canalenlargement- Root canal lengthmeasurement(When connectedto Apex Locator) | - Canalenlargement- Root canal lengthmeasurement | Same | |
| Indication foruse | The EQ-Mmotorized | The Tri Auto minimotorized | The Tri Auto ZX2device is a cordless | Same | |
| handpiece can beused to enlargeand prepare rootcanals,remove gutta-percha points.When connected toApex locator (EQ-PEX), the EQ-Mcanbe used tomeasure the lengthof root canals. | handpiece can beused to enlargeand prepare rootcanals, removegutta-perchapoints, and forprofessional toothcleaning. Whenconnected to Apexlocator, the Tri Automini can be used tomeasure the lengthof root canals. | endodontictreatmentmotorizedhandpiece with rootcanal measurementcapability. It can beused to enlargecanals whilemonitoring theposition of the filetip inside the canal.It can be used as alow-speedmotorizedhandpiece anddevice formeasuring canallength. | |||
| DeviceDescription | EQ-M is micromotor needed tomake canalenlargement forroot canaltreatment. Thebattery in the motorhandpiece is usedas a power sourceand the rotationalpower generatedby rotating themicro motor istransmitted to thecrown gear of theangle head throughthe bevel gear andshaft. The resultingrotational power istransmitted to thefile to rotate the file.When connected toApex Locator (EQ-PEX), the EQ-Mindicates theposition of the filetip inside the rootcanal.The EQ-PEX isElectronic ApexLocator andaccessories to beused to treatpatients. It consistsof the main bodyand lip hook, probe | The Tri Auto mini isa battery- drivenhandpiece with amotor, equippedwith the chuck forholding rotaryinstrument such asa dental file and areamer. Tri Automini can be usedfor enlargementand preparation ofroot canals. Whenconnected to ApexLocator (Which isnot included in thisapplication), the TriAuto mini indicatesthe position of thefile tip inside theroot canal. | The Tri Auto ZX2 isa battery-drivenhandpiece with amotor, equippedwith achuck for holdingrotary instrumentssuch as a dentalfile and reamer.TheTri Auto ZX2 canbe used for cuttingand grinding teethby transferringrotarymovement to arotary instrumentattached to thehead. Cutting andgrinding ofteeth can be donedepending on thesituation byswitching(reversing) therotationdirection. Rotationspeed isaccelerated ordeceleratedaccording to theuser'spreference, rotationcontrol based ontorque detection, orset timing. Thesecontrols enable the | Same | |
| cord. The device isused to track theposition of the filein the root canalbased on theimpedance of twodifferentfrequencies.The screendisplaysmeasurementinformation of theroot canal length atthe current locationof the file anddisplays a numberand graph.Stainless steelhand files areintended to be usedwith the subjectdevice. Lip hook isintended to beplaced on theopposite lip of thetooth to be workedon. The file isslowly inserted intothe root canal.When the fileapproaches theapex referencevalue an alarm willbeep and the textapex will appear onthe measurementscreen. | cutting, grinding,enlargement, andpreparation of rootcanals.Moreover, the TriAuto ZX2 can beused for theremoval ofextraneousmaterialssuch as gutta-percha points, andfor professionalmechanical toothcleaning.In addition, the TriAuto ZX2 can beused as an apexlocator, and themeasuredvalue can be usedfor rotation control. | ||||
| Usage | Prescription Use | Prescription Use | Prescription Use | Same | |
| Technical Specification | |||||
| Energy usedand/ordelivered | Li-ion battery(DC 3.7V) | Li-ion battery(DC 3.7V) | Li-ion battery(DC 3.7V) | Same | |
| ExteriorDesign | 28 mm x 27.2 mm x154.4mmCharger: 80 mm x83 mm x 89.5 mm | 18 mm x 18 mm x165 mmCharger: 85 mm x108 mm x 68 mm | 30 mm x 30mm x200 mmCharger: 85 mm x85mm x 75 mm | Different (1) | |
| Performance 1- canalenlargement | 100-1,000rpm,4Ncm | 50-1,000rpm,4Ncm | 100-1,000rpm,4Ncm | Same | |
| Performance 2- apex locator | Accuracy of theroot apex locatorfunction: -0.5mm to+0.5mm from Apexposition | - | Accuracy of theroot apexlocator function : -1.5mm to+0.5mm for Apexposition. | Different (2) | |
| Setting Mode | EAL: When theApex Locator andEQ-M areconnected properly.CW: The motorrotates clockwise.CCW: The motorrotatescounterclockwise.RCP: The motoralternates betweenclockwise andcounterclockwiserotation.ART: The motorrotates clockwisewhile changing itsspeed. | Linked function:These functions areavailable only whenconnected to theElectronic ApexLocator.Fwd: The motorrotates clockwise.Rev: The motorrotatescounterclockwise.Torque Reverse:nine torque reversesettingsAuto controls: Autotorque Reverse/Auto torqueslowdown | EMR Mode: Thismode is for canalmeasurement.CW Mode: Themotor rotatesclockwise.OGP Mode:Optimum GlidePath function isused for canalnegotiation andmaking the glidepath. | Different (3) | |
| Display setting | 1.Memory number2. EQ-M and ApexLocator connection3. Battery Power4. Motor operationinformation1) CW: RotationDirection2) RPM: MotorSpeed3) Ncm: Torque4) STP: The motorstops when itreaches the settorque limit. | 1.Memory number2. RotationDirection3. Battery Power4. Speed Setting5. Torque ReverseSetting | 1. Memory Number2. Battery Power3. Operation Mode4. Speed Setting5. Torque LimitSetting | Same. | |
| Spray nozzle | Spray nozzle | - | Spray nozzle | Same | |
| Sterility | Contra angle(Lip hook are notattached) | Contra angle(File holder andContrary electrodeare not attached) | File holder,contrary electrode,and contra angleare autoclavable. | Same | |
| Applied Standards | |||||
| Standards met | IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 62304ISO 14971ISO 10993-1ISO 10993-5ISO 10993-10ISO 17665-1ISO 17665-2 | IEC 60601-1IEC 60601-1-2IEC 60601-1-4IEC 60601-1-6ISO 14971ISO 10993-1ISO 10993-5ISO 10993-12ISO 17664 | IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 62304IEC 62366ISO 14971ISO 10993-1ISO 10993-5ISO 10993-12ISO 15223-1 | Different (4) | |
| ISO 11737-1IEC 62366-1IEC 62133-2IEC 80601-2-60ISO 14457ISO 1797-1ISO 7405ISO 15223-1 | ISO 17664 | ||||
| Materials | Materialsconform to ISO10993. | Materialsconform to ISO10993. | Materialsconform to ISO10993. | Same | |
| Compatibilitywithenvironmentand otherdevices. | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Same | |
| ElectricalSafety | Conform to IEC60601-1 | Conform to IEC60601-1 | Conform to IEC60601-1 | Same | |
| MechanicalSafety | Conform to IEC60601-1 | Conform to IEC60601-1 | Conform to IEC60601-1 | Same | |
| Thermal Safety | Conform to IEC60601-1 | Conform to IEC60601-1 | Conform to IEC60601-1 | Same | |
| Radiationsafety | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Conform to IEC60601-1-2 | Same |
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Justifications for differences between proposed device and the predicate device are shown as below: Different (1): The exterior design of the EQ-M compared to the Tri Auto mini has slightly changed for design. However, the structures of both devices which include the contra angle that connects and rotates the files are substantially equivalent. Moreover, the principle of controlling the rotation by measurement result, load value, setting etc. is also substantially equivalent. The structure to which the probe code of the Apex locator is connected is also substantially equivalent.
Different (2): The accuracy of the root apex locator is within the accuracy of the Tri Auto ZX II reference predicate device, thus substantially the equivalent.
Different (3): The names of the modes are different, but the functions are substantially identical. Different (4): The standards applied to the EQ-M include those of predicate devices, so there is no effect on safety and effectiveness.
Non-Clinical Study performance
To be in compliance with electromagnetic safety and compatibility, appropriate study has been applied to the subject device in accordance with the following standard
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
|---|---|
| IEC 60601-1:2005 + A1:2012 | Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part1-2: Generalrequirements for basic safety and essential performance –Collateral standard: Electromagnetic compatibility –Requirements and tests |
| IEC 60601-1-6: 2010/AMD1:2013 | Medical electrical equipment - Part 1-6: Generalrequirements for safety and essential performance -Collateral standard: Usability |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usabilityengineering to medical devices |
| IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes |
| IEC 62133-2:2017 | Secondary cells and batteries containing alkaline or othernon-acid electrolytes - Safety requirements for portablesealed secondary cells, and for batteries made from them,for use in portable applications |
| ISO 15223-1:2021 | Medical devices - Symbols to be used with medical devicelabels, labelling and information to be supplied - Part 1:General requirements |
| ISO 7010:2019 | Graphical symbols - Safety colors and safety signs -Registered safety signs |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluationand testing within a risk management process |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Test for invitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization |
| ISO 11737-1:2018 | Sterilization of health care products - Microbiologicalmethods - Part 1: Determination of a population ofmicroorganisms on products |
| IEC 80601-2-60:2019 | Medical electrical equipment - Part 2-60: Particularrequirements for basic safety and essential performance ofdental equipment |
| ISO 14457:2017 | Dentistry - handpieces and motors |
| ISO 1797:2017 | Dentistry - Shanks for rotary and oscillating instruments |
| ISO 7405:2018 | Dentistry - Evaluation of biocompatibility of medical devicesused in dentistry |
| FDA Reprocessing Guidance | Reprocessing Medical Devices in Health Care Settings:Validation Methods and Labeling |
| FDA Software Guidance | Guidance for the Content of Premarket Submissions forSoftware Contained in Medical Devices |
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Conclusion
Subject device has the same device characteristics as the predicate device, based on the information provided in this summary we conclude that subject device is substantially equivalent to the predicate device.
§ 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.