TRAUS Dental Handpieces

K182892 · Saeshin Precision Co., Ltd. · EGS · Nov 26, 2019 · Dental

Device Facts

• Record ID: K182892
• Device Name: TRAUS Dental Handpieces
• Applicant: Saeshin Precision Co., Ltd.
• Product Code: EGS · Dental
• Decision Date: Nov 26, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN 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 and teeth bone for e.g. impacted third molars and complicated extractions

Device Story

TRAUS Dental Handpieces (models CRB46LN, CRB46NN) are gear-driven, hand-held dental instruments with 20:1 gear ratio. Devices attach to torque-adjustable electrical motors via ISO 3964 coupling. Head clamp accepts instruments per ISO 1797-1. Used by dental professionals in clinical settings for surgical procedures including implant placement, bone grafting, periodontal surgery, and tooth extraction. Handpieces facilitate access to difficult-to-reach areas for cavity preparation and cleaning. Output is mechanical rotation of dental burs/instruments; healthcare providers use visual and tactile feedback during operation to perform surgical tasks. Benefits include precise bone and tooth manipulation during complex dental surgeries.

Clinical Evidence

Bench testing only. Compliance with ISO 14457:2017 (Dentistry - Handpieces and Motors) verified. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation). Sterilization validated per ISO 17665-1/2 and FDA reprocessing guidance.

Technological Characteristics

Gear-driven handpiece; 20:1 gear ratio; 40,000 rpm max speed (2,000 rpm reduced). Materials: SUS303F (head/nozzle, hard chrome coated), SUS420F (chuck/gear, vacuum heat treated), SUS304 (pipe, hard chrome coated). ISO 3964 coupling; ISO 1797-1 chuck. Push-button locking. Steam sterilization (132°C/4 min).

Indications for Use

Indicated for dental procedures including implant placement (osteotomy preparation, bone contouring/osteoplasty), periodontal surgeries (bone contouring, alveoplasty, exostosis removal), bone grafting (donor site preparation, autogenous bone harvesting, sinus elevation, alveolar socket grafting), and tooth/bone removal/sectioning (impacted third molars, complicated extractions).

Regulatory Classification

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.

Predicate Devices

• STRONG Dental Handpieces (K171436)

Submission Summary (Full Text)

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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 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.

November 26, 2019

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

Re: K182892

Trade/Device Name: TRAUS Dental Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EGS Dated: August 21, 2019 Received: September 3, 2019

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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K182892

Device Name TRAUS Dental Handpieces

Indications for Use (Describe)

The TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN 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 and teeth bone for e.g. impacted third molars and complicated extractions

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

| <span> <b> <span style="font-size: 16px;">☑</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------|
| <span> <b> <span style="font-size: 16px;">☐</span> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/0 description: The image shows the logo for SAESHIN. The logo features a blue geometric shape above the company name, which is also in blue. Below the logo is the company's address, which includes "echeon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu".

# 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-Tel: [phone] / Fax: [phone]

#### 510(k) Summary

[As required by 21 CFR 807.92]

#### 1. 510(k) Number

K182892

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

November 20, 2019

## 3. 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

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

| • | Trade Name: | TRAUS Dental Handpieces |
|---|----------------------------|----------------------------------------------------------|
| • | Classification Name: | Dental Handpieces and Accessories |
| • | Common Name: | Handpiece, Contra- And Right-Angle Attachment,<br>Dental |
| • | Classification Panel: | Dental |
| • | Classification Regulation: | 21 CFR 872.4200 |
| • | Product Code: | EGS |
| • | Device Class: | I |

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Image /page/4/Picture/0 description: The image shows the logo and contact information for 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. The telephone number is [phone] and the fax number is [phone].

# 5. 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: K171436 ●
- Applicant: Saeshin Precision Co., Ltd. .
- Common Name: . Dental Handpieces and Accessories
- Device Name: STRONG Dental Handpieces

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

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

The TRAUS Dental Handpieces; TRAUS CRB46LN and TRAUS CRB46NN are gear driven hand-held dental handpieces with Gear Ratio of 20:1. 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.

# 7. Indications for Use [21 CFR 807.92(a)(5)]

The TRAUS Dental Handpieces, TRAUS CRB46LN and TRAUS CRB46NN 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 and teeth bone for e.g. impacted third molars and complicated extractions

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Image /page/5/Picture/0 description: The image shows the logo for SAESHIN. The logo consists of a blue geometric shape above the word "SAESHIN" in a stylized blue font. The geometric shape is made up of several smaller shapes, creating a three-dimensional effect. The overall design is modern and corporate.

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

| | | TRAUS CRB46LN | TRAUS CRB46NN |
|-------------------|-----------------------------------|-----------------|-----------------|
| Revolu-<br>tion | Max Speed<br>in Rpm | 40,000 rpm | 40,000 rpm |
| | After the gear<br>speed reduction | 2,000 rpm | 2,000 rpm |
| Gear Ratio | | 20:1 | 20:1 |
| Weight | | approx.87g | approx.88g |
| Size | | Ø20 x 94.8mm | Ø20 x 94.8mm |
| Articles | | Low speed angle | Low speed angle |
| Standard Coupling | | ISO 3964 | ISO 3964 |

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Image /page/6/Picture/0 description: The image shows the logo and contact information for 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. The telephone number is [phone] and the fax number is [phone].

#### Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92] 9.

When compared to the predicate device (K171436), the STRONG Dental Handpieces presented in this submission has the same:

- Indications for Use .
- Device Design .
- Composition of materials .
- · Technical Specifications

| Parameter | Proposed<br>TRAUS Dental Handpieces (Model Nos.:<br>TRAUS CRB46LN, TRAUS CRB46NN) | Predicate<br>STRONG Dental Handpieces (Model Nos.:<br>ACL(B)-611, ACL(B)-621, ACL(B)-631,<br>ACL(B)-651, ACL(B)-04C) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Unknown | K171436 |
| Manufacturer | Saeshin Precision Co., Ltd | Saeshin Precision Co., Ltd. |
| Indications for Use | The TRAUS Dental Handpieces are indicated for wide range of dental procedures.<br>A. Implant placement, including<br>1. Preparation of the osteotomy site<br>2. Bone contouring, osteoplasty<br>B. Periodontal surgeries<br>1. Bone contouring & alveoplasty around living teeth<br>2. Removal of exostosis<br>C. Bone grafting<br>1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)<br>2. Harvesting autogen living bone<br>3. Sinus elevation & grafting of alveolar sockets | The Strong Dental Handpieces are indicated for wide range of dental procedures.<br>A. Implant placement, including<br>1. Preparation of the osteotomy site<br>2. Bone contouring, osteoplasty<br>B. Periodontal surgeries<br>1. Bone contouring & alveoplasty around living teeth<br>2. Removal of exostosis<br>C. Bone grafting<br>1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.)<br>2. Harvesting autogen living bone<br>3. Sinus elevation & grafting of alveolar sockets<br>D. Removal and sectioning of teeth and teeth |
| Parameter | Proposed<br>TRAUS Dental Handpieces (Model Nos.:<br>TRAUS CRB46LN, TRAUS CRB46NN) | Predicate<br>STRONG Dental Handpieces (Model Nos.:<br>ACL(B)-61I, ACL(B)-62I, ACL(B)-631,<br>ACL(B)-651, ACL(B)-04C) |
| | D. Removal and sectioning of teeth and teeth<br>bone for e.g. impacted third molars and<br>complicated extractions | bone for e.g. impacted third molars and<br>complicated extractions |
| Device Design | | |
| Operational Mode | Gear | Gear |
| Gear Ratio | 20:1 | 20:1, 16:1, 64:1, 32:1, 1:1 |
| Length | 94.8 mm | 96.9, 96.9, 99.5, 96.9, 83.3 mm |
| Diameter | Ø 20 | Ø 19.6 |
| Dia. of tool | 2.35 mm | 2.35 mm |
| Max. Overall Length of<br>Rotary Instrument | 30 mm | 30 mm |
| Head Height | 14 mm | 14.45,14.2 mm |
| Head Diameter | Ø 9.6 mm | Ø 8, Ø 7.7 mm |
| Shank | By ISO 1797-1 | By ISO 1797-1 |
| 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 | Spray Nozzle | Spanner |
| Composition of Materials<br>/Surface treatment | | |
| Gear | SUS420F/Vacuum Heat Treatment | SUS420F/Vacuum Heat Treatment |
| Shank | N/A | SUS304 |
| Head and Nozzle | SUS303F/Hard Chrome coated | SUS303F/Hard Chrome coated |
| Chuck | SUS420F/Vacuum Heat Treatment | SUS420F/Vacuum Heat Treatment |
| Handle | SUS303F/Hard Chrome coated | AL6061/Anodizing |
| Pipe | SUS304/Hard Chrome coated | SUS303F/Hard Chrome coated |
| | | 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 Push-Button Locking by ISO 1797-1 |
| Parameter | Proposed<br>TRAUS Dental Handpieces (Model Nos.:<br>TRAUS CRB46LN, TRAUS CRB46NN) | Predicate<br>STRONG Dental Handpieces (Model Nos.:<br>ACL(B)-61I, ACL(B)-62I, ACL(B)-631,<br>ACL(B)-65I, ACL(B)-04C) |
| Bur Extraction Force(N)<br>Max. Torques<br>Max. Water Pressure<br>Max. Speed in rpm<br>Shank Conformance<br>Coupling Dimension<br>Lubricant<br>Chemical Composition<br>Biocompatible<br>Delivery system | 45 N<br>80 Ncm<br>N/A<br>40,000 rpm<br>By ISO 1797-1<br>By ISO 3964<br>N/A<br>510k# | 45 N<br>50 Ncm<br>N/A<br>50,000 rpm, 35,000 rpm<br>By ISO 1797-1<br>By ISO 3964<br>N/A |
| Sterilization | Steam Heat 132 °C / 4minutes | Steam Heat 132 °C / 4minutes |
| Operating principle | The TRAUS Dental Handpieces are gear driven<br>hand-held dental handpieces with gear ratio of<br>20:1. It can be driven by torque adjustable<br>electrical motors for surgery treatment. It is<br>attached to drive via ISO 3964 coupling. The<br>head clamp accepts instrument complying with<br>ISO 1797-1. They have contra angle attachment<br>for difficult to reach areas intended to prepare<br>dental cavities for restorations, such as fillings,<br>and for cleaning teeth. | The STRONG Dental Handpieces are gear<br>driven hand-held dental handpieces with gear<br>ratio of 20:1, 16:1, 64:1, 32:1 and 1:1. It can be<br>driven by torque adjustable electrical motors<br>for surgery treatment. It is attached to drive via<br>ISO 3964 coupling. The head clamp accepts<br>instrument complying with ISO 1797-1. They<br>have contra angle attachment for difficult to<br>reach areas intended to prepare dental cavities<br>for restorations, such as fillings, and for<br>cleaning teeth. |

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Image /page/7/Picture/0 description: The image shows the logo for SAESHIN. The logo consists of a geometric shape made up of blue triangles above the company name, which is also in blue. Below the company name is the text "Dasa-eup, Dalseong-gun, Daegu".

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Image /page/8/Picture/0 description: The image shows the logo for SAESHIN, which is written in a stylized blue font. Above the company name is a geometric blue logo. Below the logo is the address: # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu.

23921, Korea
Tel: [phone] / Fax: [phone]

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Image /page/9/Picture/0 description: The image shows the contact information for a company called 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].

# 10. Summary of Non-Clinical Performance Data

#### Biocompatibility

Patient contact materials of the TRAUS Dental Handpieces are as follows:

#### 1) TRAUS CRB46LN, TRAUS CRB46NN

| Part | Material | Surface<br>treatment | Patient<br>contact | Duration of Contact<br>by ISO 10993-1 | Bio-<br>compatibility |
|--------------------|----------|--------------------------|--------------------|---------------------------------------|-----------------------|
| Head and<br>nozzle | SUS303F | Hard Chrome<br>Coated | Yes | Limited (<24 hours) | Yes |
| Chuck | SUS420F | Vacuum heat<br>treatment | Yes | Limited (<24 hours) | Yes |

- Cytotoxicity per ISO 10993-5
- . Sensitization per ISO 10993-10
- . Irritation per ISO 10993-10

#### Bench Testing

The bench tests were performed in order to ensure the performance of the TRAUS Dental Handbieces: TRAUS CRB46LN and TRAUS CRB46NN verify conformity to ISO 14457 and demonstrate substantial equivalence to the predicates.

TRAUS CRB46LN and TRAUS CRB46NN samples were compliant with ISO 14457: 2017 Dentistry - Handpieces and Motors and demonstrated substantial equivalence to the predicates.

#### I Sterilization

The TRAUS Dental handpieces, TRAUS CRB46LN and TRAUS CRB46NN are provided nonsterile and labeled for sterilization by the end user, the Instructions for use include the following parameters:

| Sterilization Type | Temperature | Time | Load<br>Characteristics | Dry Time |
|------------------------------------------|-------------|--------|-------------------------|----------|
| Steam Sterilization<br>(Pre-vacuum Type) | 132 °C | 4 min. | Sterilization Bag | 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

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

# 11.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 Precision Co., Ltd. Concludes that the TRAUS Dental Handpieces are substantially equivalent to predicate devices as described herein.