High-Speed Air Turbine Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Straight Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Geared Angle Handpieces:
It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Air Motors:
It is 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

The proposed device is used to hold rotary instruments such as burs and drills for cutting, grinding, and drilling operations. The dental handpieces are hand-held instruments driven by air motor, thus driving the rotation of dental attachments for the purpose of drilling and tooth cutting. Some models include an electric connection to power an LED light

AI/ML Overview

This document describes the regulatory submission for dental handpieces (High-Speed Air Turbine, Straight, Geared Angle Handpieces, and Air Motors). The goal of the submission is to prove the substantial equivalence of the proposed device to existing predicate devices, not to prove clinical safety or effectiveness for a new medical device. Therefore, a traditional "acceptance criteria" and "study that proves the device meets acceptance criteria" as one might see for a diagnostic AI device is not applicable here.

Instead, the submission focuses on non-clinical testing and comparison to predicate devices to demonstrate that the new device is as safe and effective as those already on the market.

Here's an analysis based on the provided document, addressing the prompt's points where applicable, and explaining why others are not relevant in this context:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (dental handpiece), "acceptance criteria" are typically defined by compliance with recognized international standards and performance benchmarks relative to the predicate devices. The document does not present a formal "acceptance criteria table" with specific thresholds for outcomes related to a diagnostic or therapeutic AI. Instead, it demonstrates compliance through non-clinical testing against standards and comparison to predicate device specifications.

The "performance" of the device is implied by its adherence to these standards and functional similarity to the predicate.

Here's a table summarizing the differences identified and the justification for substantial equivalence, which acts as the "performance" verification in this context:

Item	Acceptance Criterion (Compliance)	Reported Device Performance (Justification for SE)
Air/water ports	Does not affect safety and effectiveness.	Proposed device has 2/4/6 ports, predicate has 2/4 ports. Differences justified as not affecting safety/effectiveness based on non-clinical tests.
Composition	Biocompatibility requirements per ISO 10993-1.	Proposed device uses Copper (chromium plating), aluminum, rubber, stainless steel. Biocompatibility tested per ISO 10993-5, -10, -23, -11, and USP <151>. Results meet requirements.
Bur extraction	Meets ISO 14457 requirement of at least 22 N.	Proposed device has 22N, predicate has 28N. Meets the ISO 14457 standard (at least 22 N).
Speed in rpms	Proposed device's speed range covered by predicate's speed range and meets use requirement (ISO 14457).	Proposed device: High-speed Air Turbine 280,000-450,000 rpm; Straight/Geared Angle/Air Motors <40,000 rpm. Predicate: High-speed 300,000-400,000 rpm; Low-speed 18,000-20,000 rpm. Proposed device's speed range is covered by the predicate's. Tested per ISO 14457.
Safety Standards	Compliance with relevant electrical safety, EMC, biocompatibility, and sterilization standards.	Proposed device complies with: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 80601-2-60, ISO 10993 series (-5, -10, -11, -23), USP <151>, ISO 14457, ISO 17664, ISO 17665-1, ISO 9168. Consistent with predicate's compliance.

2. Sample size used for the test set and the data provenance:

Test Set: Not applicable for a traditional "test set" in the context of an AI/diagnostic algorithm. The "testing" here refers to bench testing (non-clinical) of physical devices against engineering specifications and international standards. The sample size would refer to the number of physical units tested, but this detail is not provided in a P(K) summary, as it's standard engineering verification.
Data Provenance: Not applicable in the sense of patient data. The "data" comes from engineering measurements and tests performed on the physical dental handpieces.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth, in this context, is established by adherence to international engineering standards (e.g., ISO, IEC, ANSI/AAMI) and direct comparison of physical properties with legally marketed predicate devices. No human expert consensus on medical image interpretation or clinical outcomes is needed for this type of device.

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

Not applicable. This concept pertains to expert review and consensus in diagnostic studies, which is not relevant here.

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:

Not applicable. This device is a mechanical dental instrument, not an AI or diagnostic tool that assists human readers. No MRMC study was performed. The "Clinical Test Conclusion" (Page 6, Section 8) explicitly states: "No clinical study is included in this submission."

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

Not applicable. This is not an algorithm; it's a mechanical device.

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

The "ground truth" for this submission is based on:
- International Standards: Adherence to established standards such as ISO 14457 (Dentistry - Handpieces and motors), IEC 60601 series (Medical electrical equipment), ISO 10993 series (Biological Evaluation of Medical Device), etc.
- Predicate Device Specifications: Direct comparison of the proposed device's specifications and performance to those of the legally marketed predicate devices (K181691 and K202786). The argument for "Substantial Equivalence" is built on demonstrating that any differences do not raise new questions of safety or effectiveness.
- Bench Testing Results: Data derived from physical performance tests (e.g., bur extraction force, speed measurements, biocompatibility tests).

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. No training set for an AI model.

In summary:

This FDA 510(k) submission for dental handpieces is a pre-market clearance based on substantial equivalence to existing devices. The "acceptance criteria" are met by demonstrating compliance with recognized performance standards and by showing that any differences from the predicate devices do not introduce new safety or effectiveness concerns, primarily through non-clinical bench testing and adherence to international engineering and safety standards. Clinical studies or AI-specific performance metrics (like MRMC, standalone algorithm performance, or expert ground truthing) are not required or relevant for this type of device submission.

Summary

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September 22, 2023

Foshan COXO Medical Instrument Co., Ltd. % Ray Wang Official Correspondent Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K220179

Trade/Device Name: High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB, EGS Dated: September 1, 2023 Received: September 1, 2023

Dear Ray Wang:

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.

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., CQIA 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) K220179

Device Name

High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors

Indications for Use (Describe)

High-Speed Air Turbine Handpieces:

It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Straight Handpieces:

It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Geared Angle Handpieces:

It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Air Motors:

It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Type of Use (Select one or both, as applicable)

☑ Remediation Use (Part 21 CFR 601.3 Subpart D)
☐ Own-Use Exception (21 CFR 601.3 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K220179

Date of Preparation 1.
09/21/2023
1. Sponsor

Foshan COXO Medical Instrument Co., Ltd.

BLDG 4, District A Guangdong New Light Source Industrial Base, South of Luocun Avenue Nanhai District Foshan 528226 Guangdong China

Contact Person: Zheng yongjian Position: Legal Representative Tel: 13702544788 Fax: 0757-81800058 Email: 13702544788@163.com

1. Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com

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1. Identification of Proposed Device
  Trade Name: High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/ Air Motors Common Name: Dental Handpiece and Accessories Model(s): High-Speed Air Turbine Handpieces CX207, CX207-G, CX207-2, CX207-A, CX207-A-2, CX207-B, CX207-B-2, CX207-C, CX207-C-2, CX207-W, CX207-W-2

Straight Handpieces CX235-2, CX235-2A, CX235-2B, CX235-2F, CX235-2G, CX235-2C, CX235- 2S2

Geared Angle Handpieces CX235-1B, CX235-1C, CX235-1F, CX235-1G, CX235C1, CX235C2, CX235C3, CX235C4, CX235C5, CX235C6, CX235C7, CX235C8, CX235-2S, CX235-2S1

Air Motors: CX235-3B, CX235-3F, CX235-3C

Regulatory Information: Regulation Name: Dental Handpiece And Accessories Classification: I; Product Code: EFB; Additional Product Code: EGS; Regulation Number: 21 CFR 872.4200; Review Panel: Dental;

Indications for Use Statement:

High-Speed Air Turbine Handpieces:

It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Straight Handpieces:

It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Geared Angle Handpieces:

It is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Air Motors:

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It is 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 5.

6. Identification of Predicate Device

Primary Predicate Device: 510(k) Number: K181691 Product Name: High-Speed Air Turbine Handpiece / Low-Speed Air Turbine Handpiece Manufacturer: Foshan Wenjian Medical Instrument Co., Ltd.

Reference Device: 510(k) Number: K202786 Product Name: Dental Low-speed Handpieces and Accessories Manufacturer: MicroP Technology (Taiwan), Inc.

Non-Clinical Test Conclusion 7.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ANSI/AAMI ES60601-1:2005/(R)2012 And A1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests:
IEC 80601-2-60: 2019. Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment;
ISO 10993-5:2009, Biological Evaluation of Medical Device-Part 5: Tests for Vitro > cytotoxicity;
ISO 10993-10:2021, Biological Evaluation of Medical Device-Part 10: Test for irritation and delay-type hypersensitivity:
ISO 10993-23:2021, Biological Evaluation of Medical Device – Part 23: Tests for irritation:
ISO 10993-11:2017, Biological Evaluation of Medical Device – Part 11: Test for systemic toxicity;
Pyrogen Study in Rabbits using USP General Chapter <151> Pyrogen Test;
A ISO 14457 Second edition 2017-10 Dentistry - Handpieces and motors;

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ISO 17664 Second edition 2017-10 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 17665-1 First edition 2006-08-15 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces
1. Clinical Test Conclusion

No clinical study is included in this submission.

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9. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Primary Predicate Device	Reference Device	Remark
Manufacturer	Foshan COXO Medical Instrument Co., Ltd.	Foshan Wenjian MedicalInstrument Co., Ltd.	MicroP Technology (Taiwan), Inc.	--
Device Name	High-Speed Air Turbine Handpieces/ Straight Handpieces/ Geared AngleHandpieces/ Air Motors	High-speed air turbine handpieceLow-speed air turbine handpiece	Dental Low-speed Handpieces andAccessories	--
Model	High-Speed Air Turbine Handpieces:CX207, CX207-G, CX207-2,CX207-A, CX207-A-2, CX207-B, CX207-B-2, CX207-C, CX207-C-2,CX207-W, CX207-W-2Straight Handpieces: CX235-2, CX235-2A, CX235-2B, CX235-2F,CX235-2G, CX235-2C, CX23 5-2S2Geared Angle Handpieces: CX235-1B, CX235-1C, CX235-1F,CX235-1G, CX235C1, CX235C2, CX235C3, CX235C4, CX235C5,CX235C6, CX235C7, CX235C8, CX235-2S, CX235-2S1Air Motors:CX235-3B, CX235-3F, CX235-3C	Dental High-speed TurbineHandpiece (WJ-114, WJ- 112,WJ-124, WJ -122, WJ- 134, WJ-132, WJ - 144, WJ -142, WJ-154, WJ - 152, WJ -164, WJ-162)Dental Low-speed TurbineHandpiece (WJ-414, WJ- 412,WJ-424, WJ-422)	Contra-angle Handpieces: G25, G25L,G23Straight Handpieces: G65, G65L, G63	--
Product Code	EFB, EGS	EFB, EGS	EFB, EGS	SAME
Regulation No.	21 CFR 872.4200	21 CFR 872.4200	21 CFR 872.4200	SAME
Class	I	I	I	SAME
Indication	High-Speed Air Turbine Handpieces:It is intended for removing carious material, excess filling material, cavityand crown preparation, finishing tooth preparations and restorations, rootcanal preparations and polishing teeth.Straight Handpieces:It is intended for removing carious material, excess filling material, cavityand crown preparation, finishing tooth preparations and restorations, rootcanal preparations and polishing teeth.	Dental High-speed TurbineHandpiece (WJ-114, WJ- 112,WJ-124, WJ -122, WJ- 134, WJ-132, WJ - 144, WJ -142, WJ-154, WJ - 152, WJ -164, WJ-162) is intended for removingcarious material, excess fillingmaterial, cavity and crownpreparation, finishing toothpreparations and restorations, root	MicroP Dental Low-speed Handpiecesand Accessories is intended for removingcarious material, excess filling material,cavity and crown preparation, finishingtooth preparations and restorations, rootcanal preparations and polishing teeth.All the devices are designed for use by atrained professional in the field ofgeneral dentistry	SAME
	Geared Angle Handpieces:It is intended for removing carious material, excess filling material, cavityand crown preparation, finishing tooth preparations and restorations, rootcanal preparations and polishing teeth.Air Motors:It is intended for removing carious material, excess filling material, cavityand crown preparation, finishing tooth preparations and restorations, rootcanal preparations and polishing teeth.	canal preparations and polishingteeth.Dental Low-speed TurbineHandpiece (WJ-414, WJ- 412,WJ-424, WJ-422) is intended forremoving carious material, excessfilling material, cavity and crownpreparation, finishing toothpreparations and restorations, rootcanal preparations and polishingteeth.
Air/water ports	2/4/6 ports	2/4 ports	up to four	DIFFERENT 1
Fiberoptic Glass Rod	CX207-G, CX235-1C, CX235C7	Included in model WJ-162,WJ-164, WJ-424and WJ- 422Disposable	Included in model G25Land G65L	SAME
Accessories	NA	NA	NA	SAME
Composition of material	Copper (chromium plating), aluminum , rubber and stainless steel	Stainless steel, Brass, Aluminum,Titanium	Stainless steel, Aluminum Alloy	DIFFERENT 2
Chuck	Push button, Screw	Push button, Screw	Push button	SAME
Bur extraction force	22N	28N	/	DIFFERENT 3
Maximum air pressure	High-speed Air Turbine Handpieces:0.2-0.25MpaStraight handpiece & Geared Angle handpiece & Air Motors:0.245MPa~0.3925MPa	Dental High-speed TurbineHandpiece: 200kPa ~ 250kPa(29.01 psi~ 36.25 psi) DentalLow-speed Turbine Handpiece:245 ~ 392 kPa (35.53 psi~ 56.85psi)	0.248-0.296MPa(36psi~43psi)	SAME
Maximumpressure	water	High-Speed Air Turbine Handpieces:0.2-0.25MpaStraight handpiece & Geared Angle handpiece & Air Motors:0.245MPa~0.3925MPa	Dental High-speed TurbineHandpiece: 200kPa ~ 250kPa(29.01 psi~ 36.25 psi)Dental Low-speed TurbineHandpiece: 245 ~ 392 kPa (35.53psi~ 56.85 psi)	0.248-0.296MPa(36psi~43psi)	SAME
Speed in rpms		High-speed Air Turbine Handpieces:280000 ~450000Straight handpiece &Geared Angle handpiece&Air Motors: <40000rpm	Dental High-speed TurbineHandpiece: 300,000rpm ~400,000rpmDental Low-speed TurbineHandpiece: 18,000 ~ 20,000 rpm	<40000rpm	DIFFERENT 4
Conformancewithstandards for shanks		Type 3 per ISO 1797-1	Type 3 per ISO 1797-1	/	SAME
Coupling dimensions		Complied with ISO 3964	Complied with ISO 3964	/	SAME
Hose connections		Type 1 for 2-hole model / Type 2 for 4- holemodel/Type 3 for 6-hole model	Type 1 for 2-hole model / Type 2for 4- hole model	/	SIMILAR
Lubricant		The lubricants approved by FDA, such as DO-ALL Dental HandpieceLubricant(K073353).	The specified lubricant, type"PANA SPRAY Plus"manufactured by NAKANISHIINC (cleared in K163483), mustbe used during routinemaintenance.	MicroP Halley Spray	SIMILAR
Compliance Standards		Complied with ISO 10993- 5, ISO 10993-10, ISO 10993-23, ISO10993-11, USP <151> Pyrogen Testing, IEC 60601-1, IEC 60601-1-2, IEC80601- 2-60, ISO14457, ISO 17665-1, ISO 17664, ISO 9168	Complied with ISO 10993- 5, ISO10993-10, IEC 60601-1, IEC80601- 2-60, ISO14457, ISO17665, ISO 11138, ISO 11607,ISO 17664	Complied with ISO 10993- 5, ISO10993-10, ISO14457	SAME

Table 7-3 General Comparison

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10. Substantially Equivalent (SE) Conclusion

DIFFERENT 1

The difference between proposed device and predicate device is Air/water ports, which is use for connection, the difference does not affect the safety and effectiveness of proposed device. Based on the nonclinical tests performed, the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device.

DIFFERENT 2

The Handpiece is tissue-contacting, so it is tested accordance with the requirements of ISO 10993-1 and guidelines. The test results meet the requirements. Based on the biological test results, the proposed device is as safe, and performs as well as the legally marketed predicate device.

DIFFERENT 3

The difference between proposed device and predicate device is bur extraction force. The ISO 14457 required the bur extraction force shall be at least 22 N for Type 5. Based on the nonclinical tests performed, the proposed device meets the standard and is as safe, as effective, and performs as well as the legally marketed predicate device.

DIFFERENT 4

The difference between proposed device and predicate device is Speed. The proposed device's speed range is covered by the Predicate Device's speed range. Therefore, the proposed device's speed range can meet the use requirement. We tested as ISO 14457, based on the nonclinical tests performed, the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device.

Conclusion: Based on the comparison of technological characteristics, demonstrated through bench testing and intended use, the proposed 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.