STRONG Dental Handpieces

• K Number: K171436
• Device Name: STRONG Dental Handpieces
• Manufacturer: Saeshin Precision Co., Ltd.
• Date Cleared: 2018-01-05 ( 234 days)
• Product Code: EGS
• Regulation Number: 872.4200
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: K092412
• Predicate For: K182892

Intended Use

The STRONG Dental Handpieces, ACL(B)-611, ACL(B)-631, ACL(B)-651 and ACL(B)-04C are intended for a wide range of dental procedures including:

• A. Implant placement, including
• 1. Preparation of the osteotomy site
• 2. Bone contouring, osteoplasty

B. Periodontal surgeries

• 1. Bone contouring & alveoplasty around living teeth

2. Removal of exostosis

C. Bone grafting

• 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
• 2. Harvesting autogen living bone
• 3. Sinus elevation & grafting of alveolar sockets

D. Removal and sectioning of teeth bone for e.g. impacted third molars and complicated extractions

Device Description

The STRONG Dental Handpieces; ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-65| and ACL(B)-04C are gear driven hand-held dental handpieces with Gear Ratio of 20:1, 16:1, 64:1, 32:1 and 1:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the "STRONG Dental Handpieces" based on the provided FDA 510(k) summary (K171436):

1. Table of Acceptance Criteria and Reported Device Performance:

The document for the "STRONG Dental Handpieces" focuses on demonstrating substantial equivalence to a predicate device (K143418) rather than defining specific, quantitative acceptance criteria for de novo performance. The acceptance criteria are implicitly that the new device meets the same performance and safety standards as the predicate, as evidenced by similar technical specifications and successful bench testing against relevant standards.

Acceptance Criteria Category	Specific Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Intended Use	Identical to predicate device	Identical to predicate device
Device Design	Similar to predicate device	Similar to predicate device
Composition of Materials	Similar to predicate device	Similar to predicate device (with minor variations noted)
Technical Specifications	Comparable to predicate device (within acceptable ranges for variations)	See detailed comparison table in Section 8 of the summary (e.g., Gear Ratio, Length, Diameter, Max Speed, Torque, Shank Conformance, Coupling Dimension)
Biocompatibility	Compliance with ISO 10993-1 (Cytotoxicity, Sensitization, Irritation)	Materials previously cleared and test reports demonstrate compliance.
Bench Testing	Conformity to ISO 14457 (Dentistry - Handpieces And Motors)	All models compliant with ISO 14457:2012.
Sterilization	Validation per FDA Guidance, ASTM F2314, ISO 15883-5, ISO 17665-1, ISO 17665-2 for steam sterilization protocol.	Sterilization method validated according to listed standards for the specified protocol (Steam Heat 132 ℃ / 4 min. with sterilization bag and 30 min dry time).

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

• Test Set Description: The studies involved "ACL(B)-611, ACL(B)-62l, ACL(B)-63l, ACL(B)-65l and ACL(B)-04C samples."
• Sample Size: The exact number of samples tested for each model in the bench tests is not specified in the provided document. It states "samples were compliant," implying multiple units were tested per model.
• Data Provenance:
  • Country of Origin: Korea (Saeshin Precision Co., Ltd. is based in Republic of Korea; Biocompatibility testing done by Korea Testing & Research Institute).
  • Retrospective or Prospective: The testing appears to be prospective bench testing specifically conducted for this 510(k) submission to demonstrate compliance. Biocompatibility data leverages previous clearance (K092412) for similar materials, which would be considered retrospective in terms of the initial material assessment, but the application to the current device is part of the prospective submission.

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

• This document describes testing for a Class I dental handpiece, not an AI/Software as a Medical Device (SaMD) that typically involves expert ground truth for interpretation.
• Therefore, there is no mention of experts establishing ground truth in the context of interpretation for image analysis or clinical diagnosis. The "ground truth" for this device's performance is established by direct measurement and compliance with engineering and biocompatibility standards.
• Experts involved would typically be in engineering, materials science, and microbiology for the bench and sterilization testing, but their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set:

• Not applicable for this type of device and testing. Adjudication methods like "2+1" are relevant for clinical studies where multiple human readers interpret data, and discrepancies need to be resolved, often in the context of AI performance evaluation. This document describes bench testing against defined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No MRMC study was done. This type of study is typically performed for diagnostic imaging AI algorithms to compare human reader performance with and without AI assistance. The "STRONG Dental Handpieces" are mechanical devices, and such a study is not relevant to their evaluation.

6. Standalone Performance Study (Algorithm only):

• Not applicable. This device is a mechanical dental handpiece, not an algorithm or software. The performance described is for the physical device itself.

7. Type of Ground Truth Used:

• The "ground truth" for this device's acceptance is based on:
  • Engineering Standards: Compliance with ISO 14457:2012 for dental handpieces, and ISO 3964, ISO 1797-1 for coupling and shank conformity.
  • Biocompatibility Standards: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10.
  • Sterilization Standards: Compliance with FDA Guidance for Reprocessing, ASTM F2314, ISO 15883-5, ISO 17665-1, ISO 17665-2.
  • Direct Measurement: Technical specifications for revolution, gear ratio, weight, size, torque, etc., are directly measured and compared against the predicate and design specifications.

8. Sample Size for the Training Set:

• Not applicable. This device is a mechanical product, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no training set, this question is not relevant.

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 & 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.

Saeshin Precision Co., Ltd. Choi Jong Woo Quality Manager #52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, 42921 Republic of Korea

January 5, 2018

Re: K171436

Trade/Device Name: STRONG Dental Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EGS Dated: December 5, 2017 Received: December 5, 2017

Dear Choi Jong Woo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K171436

Device Name

STRONG Dental Handpieces

Indications for Use (Describe)

The STRONG Dental Handpieces, ACL(B)-611, ACL(B)-631, ACL(B)-651 and ACL(B)-04C are intended for a wide range of dental procedures including:

• A. Implant placement, including
• 1. Preparation of the osteotomy site
• 2. Bone contouring, osteoplasty

B. Periodontal surgeries

• 1. Bone contouring & alveoplasty around living teeth

2. Removal of exostosis

C. Bone grafting

• 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
• 2. Harvesting autogen living bone
• 3. Sinus elevation & grafting of alveolar sockets

D. Removal and sectioning of teeth bone for e.g. impacted third molars and complicated extractions

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo and contact information for Saeshin. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is [phone], and the fax number is [phone].

K171436

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(1)]

January 2, 2018

2. Submitter's Information [21 CFR807.92(a)(1)]

• Name of Applicant: Saeshin Precision Co., Ltd. .

  • 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Address: -Daegu, 42921, Republic of Korea

• . Contact Name: Jong Woo, Choi (Mr.) / Quality Manager
  • Telephone No. : [phone] -
    • Fax No. : [phone]
  • Email Address : [e-mail] -
• Registration Number: 3007958831 .

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

• Trade Name: STRONG Dental Handpieces . Classification Name: Dental Handpieces and Accessories . . Common Name: Handpiece, Contra- And Right-Angle Attachment, Dental Classification Panel: . Dental Classification Requlation: 21 CFR 872.4200 . Product Code: EGS •
  General Information

STRONG Dental Handpieces

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Image /page/4/Picture/0 description: The image shows the company information for Saeshin. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is [phone], and the fax number is [phone]. The Saeshin logo is at the top of the image.

• . Device Class: ------

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[

The identified predicate devices within this submission are shown as follows:

• 510(k) Number: K143418 •
• Applicant: • Saeshin Precision Co., Ltd.
• Common Name: Dental Handpieces and Accessories
• Device Name: STRONG Dental Handpieces, •

There are no significant differences between the Model STRONG Dental Handpieces and the predicate device. It is substantially equivalent to these devices in device design, composition of materials and technical specifications.

5. Description of the Device [21 CFR 807.92(a)(4)]

The STRONG Dental Handpieces; ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-65| and ACL(B)-04C are gear driven hand-held dental handpieces with Gear Ratio of 20:1, 16:1, 64:1, 32:1 and 1:1. They can be driven by torque adjustable electrical motors for surgery treatment. They are attached to drive via ISO 3964 coupling. The head clamp accepts instrument complying with ISO 1797-1. They have contra-angle attachment intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

6. Intended Use [21 CFR 807.92(a)(5)]

The STRONG Dental Handpieces, ACL(B)-611, ACL(B)-62l, ACL(B)-63l, ACL(B)-65l and ACL(B)-04C are intended for a wide range of dental procedures including:

• A. Implant placement, including
  • 1. Preparation of the osteotomy site
  • 2. Bone contouring, osteoplasty

General Information

STRONG Dental Handpieces

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Image /page/5/Picture/0 description: The image shows the contact information for Saeshin. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is [phone], and the fax number is [phone].

• B. Periodontal surgeries
  • 1. Bone contouring & alveoplasty around living teeth
  • 2. Removal of exostosis
• C. Bone grafting
  • 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)
  • 2. Harvesting autogen living bone
  • 3. Sinus elevation & grafting of alveolar sockets
• D. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions

7. Technological Characteristics [21 CFR 807.92(a)(6)]

		ACL(B)-61I	ACL(B)-62I	ACL(B)-63I	ACL(B)-65I	ACL(B)-04C
Revolution	Max Speedin Rpm	50,000rpm	50,000rpm	50,000rpm	50,000rpm	35,000rpm
	After the gearspeed reduction	2,500rpm	3,125rpm	781rpm	1,562rpm	35,000rpm
Gear Ratio		20:1	16:1	64:1	32:1	1:1
Weight		approx.50g	approx.50g	approx.55g	approx.50g	approx.47g
Size		Ø19.6x96.9mm	Ø19.6x96.9mm	Ø19.6x99.5mm	Ø19.6x96.9mm	Ø19.6x83.3mm
Articles		Low speedangle	Low speedangle	Low speedangle	Low speedangle	Low speedangle
Standard Coupling		ISO 3964	ISO 3964	ISO 3964	ISO 3964	ISO 3964

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Image /page/6/Picture/0 description: The image shows the logo and contact information for Saeshin. The logo is a blue geometric shape above the company name, "SAESHIN," which is written in a stylized blue font. Below the logo is the address: # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea, followed by the telephone number: [phone] and fax number: [phone].

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

When compared to the predicate device (K143418) the STRONG Dental Handpieces presented in this submission has the same:

• Intended Use •
• Device Design •
• Composition of materials •
• Technical Specifications •

Parameter	Proposed	Predicate
	STRONG Dental Handpieces (Model Nos.:ACL(B)-61I, ACL(B)-62I, ACL(B)-63I,ACL(B)-65I, ACL(B)-04C)	STRONG Dental Handpieces (Model Nos.:ACL(B)-03C, ACL(B)-03F)
510(k) Number	Unknown	K143418
Manufacturer	Saeshin Precision Co., Ltd	Saeshin Precision Co., Ltd.
Intended Use	The Strong Dental Handpieces are indicatedfor wide range of dental procedures.A. Implant placement, including1. Preparation of the osteotomy site2. Bone contouring, osteoplastyB. Periodontal surgeries1. Bone contouring & alveoplastyaround living teeth2. Removal of exostosisC. Bone grafting1. Preparation of the donor site (fore.g. symphysis and ascendingrames etc.)2. Harvesting autogen living bone	The Strong Dental Handpieces are indicatedfor wide range of dental procedures.A. Implant placement, including1. Preparation of the osteotomy site2. Bone contouring, osteoplastyB. Periodontal surgeries1. Bone contouring & alveoplastyaround living teeth2. Removal of exostosisC. Bone grafting1. Preparation of the donor site (fore.g. symphysis and ascendingrames etc.)2. Harvesting autogen living bone
Parameter	ProposedSTRONG Dental Handpieces (Model Nos.:	PredicateSTRONG Dental Handpieces (Model Nos.:
	ACL(B)-61I, ACL(B)-62I, ACL(B)-63I,ACL(B)-65I, ACL(B)-04C)	ACL(B)-03C, ACL(B)-03F)
	3. Sinus elevation & grafting of alveolarsockets	3. Sinus elevation & grafting of alveolarsockets
	D. Removal and sectioning of teeth andteeth bone for e.g. impacted thirdmolars and complicated extractions	D. Removal and sectioning of teeth andteeth bone for e.g. impacted third molarsand complicated extractions
Device Design
Operational Mode	Gear	Gear
Gear Ratio	20:1, 16:1, 64:1, 32:1, 1:1	1:1
Length	96.9, 96.9, 99.5, 96.9, 83.3 mm	83.7 mm
Diameter	Ø 19.6	Ø 19.6
Dia. of tool	2.35 mm	2.35, 1.60 mm
Max. Overall Length ofRotary Instrument	30 mm	30 mm
Head Height	14.45,14.2 mm	13.7 mm
Head Diameter	Ø 8, Ø 7.7 mm	Ø 8 mm
Shank	By ISO1797-1	By ISO1797-1
Length of Shank	9 – 12 mm	9 – 12 mm
Type of Chuck	Push-Button Locking	Push-Button Locking
Coupling Dimension	By ISO 3964	By ISO 3964
Type of Connector	Not Applied	Not Applied
Accessories	Spanner	Spanner
Composition of Materials/Surface treatment
Gear	SUS420F/Vacuum Heat Treatment	SUS420F/Vacuum Heat Treatment
Shank	SUS304	SUS304
Head and Nozzle	SUS303F/Hard Chrome coated	C3604BD-F/Hard Chrome Coated
Chuck	SUS420F/Vacuum Heat Treatment	SUS420F/Vacuum Heat Treatment
Handle	AL6061/Anodizing	AL6061/Anodizing
Pipe	SUS303F/Hard Chrome coated	N/A
Parameter	Proposed	Predicate
	STRONG Dental Handpieces (Model Nos.:	STRONG Dental Handpieces (Model Nos.:
	ACL(B)-61I, ACL(B)-62I, ACL(B)-63I,ACL(B)-65I, ACL(B)-04C)	ACL(B)-03C, ACL(B)-03F)
	N/A (ACL(B)-04C)
Patient-Contacting	Chuck, Head	Chuck, Head
Operator-Contacting	Handle, Head	Handle, Head
Technical Specification
Chuck Design	Type1 Push-Button Locking by ISO 1797-1	Type1 and Type 3 Push-Button Locking byISO 1797-1
Bur Extraction Force(N)	45 N	45 N, 22N
Max. Torques	50 Ncm	50 Ncm
Max. Water Pressure	N/A	N/A
Max. Speed in rpm	50,000 rpm, 35,000 rpm	35,000 rpm
Shank Conformance	By ISO 1797-1	By ISO 1797-1
Coupling Dimension	By ISO 3964	By ISO 3964
Lubricant
Chemical Composition	N/A	N/A
	510k#BiocompatibleDelivery system
Sterilization	Steam Heat 132 ℃/4minutes	Steam Heat 132 ℃/4minutes
Operating principle	Image: dental handpiece	Image: dental handpiece
	The STRONG Dental Handpieces, ACL(B)-611,ACL(B)-621, ACL(B)-631, ACL(B)-651and ACL(B)-04C are gear driven hand-helddental handpieces with gear ratio of 20:1,16:1, 64:1, 32:1 and 1:1. It can be driven bytorque adjustable electrical motors for	The STRONG Dental Handpieces, ACL(B)–03C and ACL(B)-03F, are gear driven hand-held dental handpieces with gear ratio of 1:1.It can be driven by torque adjustableelectrical motors for surgery treatment. It isattached to drive via ISO 3964 coupling. Thehead clamp accepts instrument complying
Parameter	ProposedSTRONG Dental Handpieces (Model Nos.:ACL(B)-61I, ACL(B)-62I, ACL(B)-63I,ACL(B)-65I, ACL(B)-04C)	PredicateSTRONG Dental Handpieces (Model Nos.:ACL(B)-03C, ACL(B)-03F)
	surgery treatment. It is attached to drive viaISO 3964 coupling. The head clamp acceptsinstrument complying with ISO 1797-1. Theyhave contra angle attachment for difficult toreach areas intended to prepare dentalcavities for restorations, such as fillings, andfor cleaning teeth.	with ISO 1797-1. They have contra angleattachment for difficult to reach areasintended to prepare dental cavities forrestorations, such as fillings, and for cleaningteeth.

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Image /page/7/Picture/0 description: The image shows the logo and address of a company called SAESHIN. The logo is a blue geometric shape. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea.

Tel: [phone] / Fax: [phone]

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Image /page/8/Picture/0 description: The image shows the logo and contact information for SAESHIN. The logo is a blue geometric shape. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is [phone] and the fax number is [phone].

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Image /page/9/Picture/0 description: The image shows the logo and contact information for SAESHIN. The logo is a blue geometric shape. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is [phone] and the fax number is [phone].

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Image /page/10/Picture/0 description: The image shows the logo and contact information for Saeshin. The logo is a blue geometric design. The contact information includes the address, which is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea, as well as the telephone number, which is [phone], and the fax number, which is [phone].

9. Summary of Non-Clinical Performance Data

| Biocompatibility

The materials contacting patients of chuck, head and nozzle were totally same and have previously cleared by by FDA through STRONG been l m plan t Handpieces (K092412) of predicate device, STRONG Dental Handpiece. The biocompatibility test report has been issued by Korea Testing & Research Institute, 7-6, Gomak-Ri, Wolgot-Myeon, Gimpo-Si, Gyunggi-Do, 415-871, Korea for the predicate is applicable to the subject device:

• · Cytotoxicity per ISO 10993-5
• · Sensitization per ISO 10993-10
• · Irritation per ISO 10993-10

The device complies with the ISO10993-1 standard, and the materials contacting patients are biocompatible.

I Bench Testing

The bench tests were performed in order to ensure the performance of the STRONG Dental Handpieces, ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-651 and ACL(B)-04C verify conformity to ISO 14457 and demonstrate substantial equivalence to the predicates.

ACL(B)-611, ACL(B)-62l, ACL(B)-63l, ACL(B)-65l and ACL(B)-04C samples were compliant with ISO 14457: 2012 Dentistry - Handpieces And Motors and demonstrated substantial equivalence to the predicates.

General Information

STRONG Dental Handpieces

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Image /page/11/Picture/0 description: The image shows the logo and contact information for SAESHIN. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 42921, Korea. The telephone number is [phone], and the fax number is [phone]. The logo is a blue geometric shape above the company name.

. Sterilization

The STRONG Dental handpieces, ACL(B)-611, ACL(B)-621, ACL(B)-631, ACL(B)-65| and ACL(B)-04C are provided nonsterile and labeled for sterilization by the end user, the Instructions for use include the following parameters:

Sterilization Type	Temperature	Time	LoadCharacteristics	Dry Time
Steam Sterilization(Pre-vacuum Type)	132 ℃	4 min.	Sterilization Baq	30 min.

The sterilization method was validated per :.

• Reprocessing validation per the FDA Guidance Document entitled, "Reprocessing . Medical Devices in Health Care Settings: Validation Methods and Labeling" dated March 17, 2015
• Cleaning Process Validation per ASTM F2314 and ISO 15883-5 .
• Sterilization Validation per ISO 17665-1 and ISO 17665-2 .

10. Conclusion [21 CFR 807.92(b)(3)]

In accordance with the Federal Food, Drug and Cosmetic, 21 CFR Part 807, and based on the information provided in this premarket notification Saeshin Presicion Co., Ltd. Concludes that the STRONG Dental Handpieces are substantially equivalent to predicate devices as described herein.

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.