(359 days)
No
The summary describes a standard endodontic device with rotary files and drills, and the "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used for grinding, cutting, and polishing work in dental oral use, which describes a tool for performing a procedure, not a device that itself delivers a therapeutic effect.
No
The device description states it is used for "grinding, cutting, and polishing work" and "endodontic surgery," which are therapeutic functions, not diagnostic. Its purpose is to perform procedures using rotary files and drills, not to identify or assess a medical condition.
No
The device description explicitly states it is an AC-powered device that includes a power unit, charging station, and contra-angle handpieces, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "standard endodontic procedures using rotary files and rotary endodontic drills." This describes a procedure performed directly on the patient's teeth, not a test performed on a sample taken from the patient.
- Device Description: The device is described as being used for "grinding, cutting, and polishing work in dental oral use" and for "endodontic surgery." These are all direct clinical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely procedural within the oral cavity.
N/A
Intended Use / Indications for Use
The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).
Product codes
EKX
Device Description
The TRAUS ENDO is an AC-powered device that includes a power unit, charging station and contra-angle handpieces, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, which are used for grinding, cutting, and polishing work in dental oral use. It is used for endodontic surgery with 600-1,000 rpm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were conducted, and the device passed all of the tests based on predetermined Pass/Fail criteria.
- · Software Verification/Validation (EN 62304).
- · Temperature Test (ISO 14457, IEC 80601-2-60)
- · Eccentricity Test (ISO 14457)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
June 24, 2022
Saeshin Precision Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, California 92612
Re: K212043
Trade/Device Name: TRAUS ENDO Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: May 16, 2022 Received: May 26, 2022
Dear Priscilla Chung:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212043
Device Name TRAUS ENDO
Indications for Use (Describe)
The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary (K212043)
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Date: 6/23/2022
2. Applicant / Submitter
Saeshin Precision Co., Ltd. # 52, Secheon-ro 1-gil, Dasa-eup Dalseonggun, Daegu, 711-814, Korea Tel: +82 53 587 2345 / Fax:+82 53 580 0918
3. U.S. Designated Agent
Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com
4. Trade/Proprietary Name:
TRAUS ENDO
5. Common Name:
Dental Handpiece
6. Classification:
Handpiece, Direct Drive, Ac-Powered (21CFR 872.4200, Product code EKX, Class I, Dental)
7. Device Description:
The TRAUS ENDO is an AC-powered device that includes a power unit, charging station and contra-angle handpieces, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, which are used for grinding, cutting, and polishing work in dental oral use. It is used for endodontic surgery with 600-1,000 rpm.
4
8. Indication for use:
The TRAUS ENDO, ACL(B)-41EP, ACL(B)-42EP, and ACL(B)-46EP, are indicated for use by dentists in standard endodontic procedures using rotary files and rotary endodontic drills (Gates-Glidden).
9. Primary Predicate Device:
- . TRAUS ENDO (K143411) by Saeshin Precision Co., Ltd.
10. Additional Predicate/Reference Device:
- . STRONG Dental Handpieces (K181129) by Saeshin Precision Co., Ltd.
- ENDO a class (K123582) by Saeyang Microtech Co., Ltd. ●
5
11. Substantial Equivalence:
| | Subject Device | Primary Predicate
Device | Predicate Device | Reference Device |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Saeshin Precision Co.,
Ltd. | Saeshin Precision Co.,
Ltd. | Saeshin Precision Co.,
Ltd. | Saeyang Microtech Co.,
Ltd. |
| Device Name | TRAUS ENDO | TRAUS ENDO | STRONG Dental
Handpieces | ENDO a class |
| 510(k) Number | K212043 | K143411 | K181129 | K123582 |
| Device
Classification Name | Handpiece, direct drive,
AC-powered | Handpiece, direct drive,
AC-powered | Handpiece, direct drive,
AC-powered | Handpiece, direct drive,
AC-powered |
| Classification
Product Code | EKX | EKX | EGS | EKX |
| Device Class | I | I | I | I |
| Regulation Number | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 | 21 CFR 872.4200 |
| Indication for Use | The TRAUS ENDO,
ACL(B)-41EP, ACL(B)-
42EP, ACL(B)-46EP, are
indicated for use by
dentists in standard
endodontic procedures
using rotary files and
rotary endodontic drills
(Gates-Glidden). | The TRAUS ENDO,
ACL(B)-41EP, ACL(B)-
42EP, and ACL(B)-45EP,
are indicated for use by
dentists in standard
endodontic procedures
using rotary files and
rotary endodontic drills
(Gates- Glidden). | The Strong Dental
Handpiece, ACL(B)-
46EP is intended for wide
range of dental
procedures, including:
A. Implant placement,
including
- Preparation of the
osteotomy site - Bone contouring,
osteoplasty
B. Periodontal surgeries - Bone contouring &
alveoplasty around living
teeth - Removal of exostosis
C. Bone grafting
1.Preparation of the donor
site (for e.g. symphysis
and ascending rames etc.) - Harvesting autogen
living bone
Sinus elevation &
grafting of alveolar
sockets - D. Removal and
sectioning of teeth and
teeth bone for e.g.
impacted third molars and
complicated extractions. | This application area
extends to endodontic
procedures using a root
canal instrument which is
intended by the
manufacturer for use in
the mechanical and
rotary preparation of root
canals. |
| Components | Contra-Angle Handpiece
Motor Handpiece Battery
Charger
Power Cord | Contra-Angle Handpiece
Motor Handpiece Battery
Charger
Power Cord | Contra-Angle Handpiece | Contra-Angle Handpiece
Motor Handpiece Battery
Charger
Power Cord |
| Gear | 10:1
16:1
20:1 | 16:1
20:1
32:1 | 10:1 | 4:1
10:1
16:1
20:1 |
6
| Chuck Type
Shank Type | Latch Type
Type 1 | Latch Type
Type 1 | Latch Type
Type 1 | Latch Type
Type 1 |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------|
| Composition of
Material | Gear: Stainless steel Shank: Stainless steel (Trimrite) & Brass Head: Stainless steel Chuck: Aluminum | Gear: Stainless steel Shank: Stainless steel (Trimrite) & Brass Head: Stainless steel Chuck: Aluminum | Gear: Stainless steel Shank: Stainless steel (Trimrite) & Brass Head: Stainless steel Chuck: Aluminum | Stainless Steel |
| Supply voltage | 100-240V AC 50/60Hz | 100-240V AC 50/60Hz | - | 100-240V AC 50/60Hz |
| Operational voltage | DC 4.5V | DV 4.5V | - | - |
| Torque moto speed | 1-4 Ncm | 1-4 Ncm | 2 Ncm | 1-4 Ncm |
| Sterilization | Contra-angle at 132°C for 4 minutes in Autoclave
conforms IEC 60601-1
IEC 60601-1-2
ISO 14457 | Contra-angle at 132°C for 4 minutes in Autoclave
conforms IEC 60601-1
IEC 60601-1-2
ISO 14457 | Contra-angle at 132°C for 4 minutes in Autoclave
conforms ISO 14457 | conforms IEC 60601-1
IEC 60601-1-2 |
| Electrical safety | | | | |
| Allows selection of
forward or Auto
reverse drive rotation | Yes | Yes | - | Yes |
| Allows reciprocation drive | Yes | No | - | Yes |
The indications for use and the technological characteristics of the subject device is the same as the predicate device, the unmodified devices. The ACL(B)-41EP and the ACL(B)-42EP are cleared under K143411 and the ACL(B)-46EP is cleared under K181129. The modification is adding reciprocation mode and we identified a reference device (K123582) which offers the same mode.
We performed risk analysis and verification/validation tests per modifications, and the test results support that the modification raises no new safety and effectiveness questions.
12. Performance Data:
The following tests were conducted, and the device passed all of the tests based on predetermined Pass/Fail criteria.
- · Software Verification/Validation (EN 62304).
- · Temperature Test (ISO 14457, IEC 80601-2-60)
- · Eccentricity Test (ISO 14457)
We also referenced the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" while preparing the software documentation.
Biocompatibility Testing per ISO 10993 was assessed under K143411, the previous cleared device, which has the same patient contacting material and manufacturing processes as the subject device.
Reprocessing Validation (i.e., Cleaning, Sterilization per ISO 17665-1) was assessed under K143411 and K181129, the previously cleared devices.
7
13. Conclusion:
The subject device is substantially equivalent in the areas of technical characteristics, general function, application, and indications for use. The subject device does not introduce a fundamentally new scientific technology, and the device has been validated through system level test. Therefore, we conclude that the subject device described in this submission is substantially equivalent to the predicate device.