(213 days)
Not Found
No
The description focuses on standard mechanical functions (grinding, cutting, polishing) and electrical safety/performance standards. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as being used in standard endodontic procedures using rotary files and drills for grinding, cutting, and polishing. These actions are directly applied to the patient to treat a dental condition, thus qualifying it as a therapeutic device.
No
The device description states it is used for "grinding, cutting, and polishing work" in dental procedures, and the intended use specifies its use with "rotary files and rotary endodontic drills" in standard endodontic procedures. These are all procedural/therapeutic actions, not diagnostic ones.
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 body.
- Device Description: The device is described as an AC-powered unit with handpieces used for "grinding, cutting, and polishing work in dental oral use." This aligns with a mechanical tool used in dental procedures, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
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).
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)-45EP, are grinding, cutting, and polishing work in dental oral use.
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)
Bench Testing:
The following bench tests were performed on the TRAUS ENDO Dental Handpieces, ACL(B)-41EP, ACL(B)-42EP, to verify conformity to standards and demonstrate substantial equivalence to the predicates:
- IEC 60601-1: Medical Electrical Equipment Part 1 (2005/(R)2012 AND a1:2012) .
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2 (2007-03) .
- ISO 14457: Dentistry-Handpieces and Motors (2012-09-15) .
- ISO 17665-1: Sterilization of health care products-Moist heat Part1 (2006-08-15) .
- ISO 1797-1: Shanks for rotary instrument - Part1 (1st edition Amendment)
- ISO 10993-1: Biological Evaluation of Medical Devices Part 1 (4th Edition) .
Results: TRAUS ENDO Dental Handpieces, ACL(B)-41EP, ACL(B)-45EP samples were compliant with standards and demonstrated substantial equivalence to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 29, 2015
Saeshin Precision Co., Ltd. Mr. Sae Kwan Choi QA Manager 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun Daegu, 711-814 REPUBLIC OF KOREA
Re: K143411 Trade/Device Name: TRAUS ENDO Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: May 26, 2015 Received: May 28, 2015
Dear Mr. Choi:
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.
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143411
Device Name
TRAUS ENDO
Indications for Use (Describe)
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).
| 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
Image /page/3/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: # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 711-814, Korea, and the telephone and fax numbers: Tel: +82 53 587 2341/ Fax: +82 53 580 0999.
K143411 510(k) Summary
[As required by 21 CFR 807.92] This 510(k) summary is prepared in accordance with 21 CFR807.92
1. Date Prepared [21 CFR 807.92(a)(1)]
6/26/2015
2. Submitter's Information [21 CFR807.92(a)(1)]
- Name of Sponsor: Saeshin Precision Co., Ltd. .
- Address: # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, -Daegu, 711-814, Republic of Korea
- Contact Name: Sae Kwan, Choi (Mr.) / Quality Manager .
- Telephone No. : +82 53 587 2341 -
- Fax No. : +82 53 580 0999 -
- Email Address : ksqc@saeshin.com -
- . Registration Number: 3007958831
- . Name of Manufacturer: Same as Sponsor
- Address: Same as Sponsor -
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- . Trade Name: TRAUS ENDO
- Common Name: Dental Handpieces
- . Classification Name: Dental Handpiece and Accessories
- . Classification Panel: Dental
- . Classification Regulation: 21 CFR 872.4200
- EKX . Product Code:
- Device Class: |
General Information
4
Image /page/4/Picture/0 description: The image contains the logo for SAESHIN, along with their address and contact information. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 711-814, Korea. The telephone number is +82 53 587 2341, and the fax number is +82 53 580 0999.
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: K123582
●
Applicant:
- Saeyang Microtech Co., Ltd.
- Common Name: Dental Handpieces ●
- . Device Name: Endo a class
- . 510(k) Number: K111616
- Applicant: Saeshin Precision Co., Ltd
- Dental Handpieces Common Name: ●
- Device Name: E-CUBE
K123582 is the primary predicate and K111616 is the reference predicate. There are no significant differences between the TRAUS ENDO dental handpieces and the predicate devices that would adversely affect the use of the product. 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 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)-45EP, are grinding, cutting, and polishing work in dental oral use.
Intended Use [21 CFR 807.92(a)(5)] 6.
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).
7. Technological Characteristics [21 CFR 807.92(a)(6)]
- Model Nos. ACL(B)-41EP, ACL(B)-42EP and ACL(B)-45EP ●
- Gear Ratio: 20:1, 16:1, 32:1
- Dimensions: Ø 16.7 X 63 mm, Ø 16.7 X 63 mm and Ø 16.7 X 63 mm .
- Weight: 34.8 g
- Charger: AC 100 - 240 V, 50 /60 Hz, DC 4.5V
One difference noted between the TRAUS ENDO and its predicates is its slower rotational speed, as a result of the 32:1 gear reduction ratio. However, equivalence to predicates has been demonstrated through bench testing and this difference raises no new concerns.
5
Image /page/5/Picture/0 description: The image shows the logo and contact information for Saeshin. The logo is a stylized blue cube. The address is # 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 711-814, Korea. The telephone number is +82 53 587 2341 and the fax number is +82 53 580 0999.
Clinical Tests
A non-clinical evaluation, based on literature research, has been done. The evaluation of the applicable market data showed that TRAUS ENDO Dental handpieces, ACL(B)-41EP, ACL(B)-42EP and ACL(B)-45EP, do not pose known or new clinical risks than similar medical devices currently on the market. Based on those results clinical test have not been executed.
6
Image /page/6/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 711-814, Korea. The telephone number is +82 53 587 2341 and the fax number is +82 53 580 0999.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
When compared to the predicate devices (K123582 and K111616), the subject device TRAUS ENDO has nearly identical:
- Intended Use .
- Device Design .
- Composition of materials .
- · Technical Specifications
The TRAUS ENDO is similar to other commercially available products based on the intended use, the claims, the material composition employed. The following tables outlines and differences between the TRAUS ENDO and the predicate devices.
| Parameter | Proposed
TRAUS ENDO | Predicate
ENDO a class | Predicate
E-CUBE |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K143411 | K123582 | K111616 |
| Manufacturer | Saeshin Precision Co., Ltd | Saeyang Microtech Co., Ltd. | Saeshin Precision Co., Ltd |
| Intended Use | 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). | ENDO a class is indicated for application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in mechanical and rotary preparation of root canals. | E-CUBE is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills(Gates- Glidden). |
| Device Design
Components | Contra-Angle Handpiece
Motor Handpiece Charging Station
Power Cord | Contra-Angle Handpiece
Motor Handpiece
Charging Stand
Motor Handpiece Cap
Power Cord
Oil Guide | Contra Box
Micro Motor
Contra-Angle Handpiece
Foot-Control Pedal
Adapter |
| Parameter | Proposed
TRAUS ENDO | Predicate
ENDO a class | Predicate
E-CUBE |
| Operational Mode | AC power and Gear driven | AC power and Gear driven | AC power and Gear driven |
| Reduction Ratio | 16:1, 20:1, 32:1 | 4:1, 10:1, 16:1 and 20:1 | 1:1, 4:1, 10:1, 16:1, 20:1 |
| Coupling Dimension | N/A | ISO 3964 connection | ISO 3964 connection |
| Chuck Type | Latch Type | Latch Type | Latch Type |
| Shank Type | Type 1 | Type 1 | Type 1 |
| Composition of Materials | | | |
| Gear | Stainless steel (SUS420F) | Not Known | Stainless steel (SUS420F) |
| Shank | Stainless steel (Biodur
Trimtite) | | Stainless steel (Biodur
Trimtite) |
| Head | Brass (C3604BD-F) | | Brass (C3604BD-F) |
| Chuck | Stainless steel (SUS420F) | | Stainless steel (SUS420F) |
| Handle | Aluminum (AL6061) | | Aluminum (AL6061) |
| Patient-Contacting | Chuck, Head | | Chuck, Head |
| Operator-Contacting | Handle, Head | | Handle, Head |
| Technical Specification | | | |
| Supply Voltage | 100-240 V AC 50/60 Hz | 100-240 V | 100-240 V AC 50/60 Hz |
| Operational Voltage | DC 4.5 V | DC 2.4 V | DC 4.5 V, 0.4 VA |
| Gear ratio | 16:1, 20:1 and 32:1 | 4:1, 10:1, 16:1 and 20:1 | 1:1, 4:1, 10:1, 16:1 and 20:1 |
| Torque | 1 -4 Ncm | 0.1 - 4.0 Ncm | 0.6 – 5.2 Ncm |
| Motor Speed | 100 – 12,000 rpm | 140 - 500 rpm | 1,000 - 13,000 rpm |
| Lubricant | | | |
| Chemical Composition | N/A | N/A | K073353 (DO-ALL Dental
handpiece Lubricant/ProDrive
Systems Inc.) |
| 510k# | | | |
| Biocompatible
Delivery system | | | |
| Sterilization | Contra-angle at 132 °C for 4
minutes in Autoclave. | Contra-angle at 121 °C for 20
minutes or 132 °C for 15
minutes in Autoclave. | Contra-angle at 134 °C for 4
minutes in Autoclave. |
7
Image /page/7/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 '# 52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun, Daegu, 711-814, Korea' and the telephone number '+82 53 587 2341' and fax number '+82 53 580 0999'.
8
| Parameter | Proposed
TRAUS ENDO | Predicate
ENDO a class | Predicate
E-CUBE | |
|-----------------------|------------------------|---------------------------|---------------------|---------|
| Performance Standards | IEC60601-1 | Conform | Conform | Conform |
| | IEC60601-1-2 | Conform | Conform | Conform |
| | ISO14457 | Conform | Conform | Conform |
9. Bench Testing
The following bench tests were performed on the TRAUS ENDO Dental Handpieces, ACL(B)-41EP, ACL(B)-42EP, to verify conformity to standards and demonstrate substantial equivalence to the predicates:
- IEC 60601-1: Medical Electrical Equipment Part 1 (2005/(R)2012 AND a1:2012) .
- IEC 60601-1-2: Medical Electrical Equipment Part 1-2 (2007-03) .
- ISO 14457: Dentistry-Handpieces and Motors (2012-09-15) .
- ISO 17665-1: Sterilization of health care products-Moist heat Part1 (2006-08-15) .
- . ISO 1797-1: Shanks for rotary instrument - Part1 (1st edition Amendment)
- ISO 10993-1: Biological Evaluation of Medical Devices Part 1 (4th Edition) .
TRAUS ENDO Dental Handpieces, ACL(B)-41EP, ACL(B)-45EP samples were compliant with standards and demonstrated substantial equivalence to the predicates.
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., we conclude that the TRAUS ENDO has been determined to the predicate devices as described herein.