(26 days)
Not Found
No
The description focuses on the mechanical and operational aspects of a dental handpiece, with no mention of AI or ML capabilities.
No.
The device is described as a dental handpiece used for removing carious material, reducing hard tooth structure, cavity preparation, and finishing tooth preparations/ restorations, which are procedures rather than therapeutic treatments.
No
Explanation: The device is a dental handpiece used for removing carious material and preparing/finishing tooth structures and restorations. Its function is to perform a physical action on the tooth, not to diagnose a condition.
No
The device description clearly states it is an "air-powered dental handpiece" and describes physical components and sterilization procedures, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device's Intended Use: The EVO 700 series High Speed Handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations/ restorations. This is a direct intervention on the patient's tooth structure, not a test performed on a sample outside the body.
- Device Description: The description clearly states it's an air-powered dental handpiece used in a clinical setting by a dentist. It's a tool for physical manipulation of the tooth.
The device's function is entirely focused on treating the patient's tooth directly, which falls under the category of a surgical or procedural dental device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The EVO 700 series High Speed Handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations/ restorations. The devices are only for dental handpieces treatment and used by a trained person in the field of dentistry.
Product codes
EFB
Device Description
EVO 700 series high speed handpiece, on the scope of 21 CFR 872.4200 Dental handpiece and accessories, product code EFB, is a modification from TTBIO's own legally market predicate device, EVO 500 series high speed handpiece, which is legally marketed on the US dental market per 510(k) clearance, No. K141183.
EVO 700 series high speed handpiece is air-powered dental handpiece that is reusable and ergonomically designed. The handpiece is connected to a dental tubing which delivers driving air, cooling air and water to the cutting bur area. Optional fiber optics deliver light to the cutting area.
This device is to be connected to dental unit and operated by qualified professional (dentist) in the clinic. EVO 700 series high speed handpiece can be connected to couplings that manufactured by TTBIO, KaVo® or NSK®. It is designed in accordance with FDA Recognized Consensus Standards of device-specific guidance document, ISO 14457:2017 Dentistry - Handpieces and motors to ensure its safety and effectiveness and follows ISO 13485:2016 Medical devices – Quality management systems – Requirements for requlatory purpose regarding to the internal design change control procedure to complete the device design steps.
EVO 700 series high speed handpiece is supplied as non-sterile and can be sterilized by gravity-displacement method, at 132°C for 15 minutes and drying for 30 minutes, and dynamic-air-removal (prevacuum) method, at 134°C for 4 minutes and drying for 15 minutes.
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
used by a trained person in the field of dentistry.
operated by qualified professional (dentist) in the clinic.
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
Not Found
Key Metrics
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/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
August 23, 2023
Ttbio Corp. Siow Woon Chyi Regulatory Affairs Coordinator 2F., No.7, 6th Road Industry Park Taichung. Taiwan 40755 China
Re: K232243
Trade/Device Name: EVO 700 series high speed handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: July 28, 2023 Received: July 28, 2023
Dear Siow Woon Chyi:
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,
Bobak Shirmohamma વા -ડ
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232243
Device Name EVO 700 series high speed handpiece
Indications for Use (Describe)
The EVO 700 series High Speed Handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations. The devices are only for dental handpieces treatment and used by a trained person in the field of dentistry.
| 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 for "TT BIO". The logo consists of two stylized "T" letters, one in blue and one in green, followed by the word "BIO" in gray. The letters are large and bold, and the word "BIO" is smaller and to the right of the letters. The logo is simple and modern, and the colors are bright and eye-catching.
TTBIO CORP. 2F., NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196
K232243 510(k) Summary
EVO 700 series High Speed Handpiece
1. General Information
| 510(k) Owner | TTBIO CORP. (Registration No.: 3010364969) |
|---|---|
| Address | 2F., No.7, 6th Road, Industry Park, Taichung, |
| Taiwan R.O.C. 40755. | |
| Applicant | Woon Chyi, Siow/ |
| Regulatory Affairs Coordinator | |
| Contact Information | Phone: 886-4-2359 5958 Ext. 731 |
| Email: siowwoonchyi@ttbio.com | |
| Date prepared | July 28, 2023 |
2. Subject Device
| Proprietary Name | EVO 700 series High Speed Handpiece |
|---|---|
| Regulation Number | 21 CFR 872.4200 |
| Regulation Name | Dental handpiece and accessories |
| Regulatory Class | Class I |
| Product Code | EFB |
| Common Name | Handpiece |
3. Predicate Device
| Proprietary Name | EVO 500 series High Speed Handpiece |
|---|---|
| Premarket Notification | K141183 |
| Regulation Number | 21 CFR 872.4200 |
| Regulation Name | Dental handpiece and accessories |
| Regulatory Class | Class I |
| Product Code | EFB |
| Common Name | Handpiece |
4. Device Description
EVO 700 series high speed handpiece, on the scope of 21 CFR 872.4200 Dental handpiece and accessories, product code EFB, is a modification from TTBIO's own legally market predicate device, EVO 500 series high speed handpiece, which is legally marketed on the US dental market per 510(k) clearance, No. K141183.
EVO 700 series high speed handpiece is air-powered dental handpiece that is reusable and ergonomically designed. The handpiece is connected to a dental tubing which delivers driving air, cooling air and water to the cutting bur area. Optional fiber optics deliver light to the cutting area.
4
Image /page/4/Picture/0 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T" shapes, one in blue and the other in green, followed by the word "BIO" in gray. The "T" shapes are connected at the top, forming a continuous design element.
TTBIO CORP 2F., NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL:886-4-23595958 FAX:886-4-23594196
This device is to be connected to dental unit and operated by qualified professional (dentist) in the clinic. EVO 700 series high speed handpiece can be connected to couplings that manufactured by TTBIO, KaVo® or NSK®. It is designed in accordance with FDA Recognized Consensus Standards of devicespecific guidance document, ISO 14457:2017 Dentistry - Handpieces and motors to ensure its safety and effectiveness and follows ISO 13485:2016 Medical devices – Quality management systems – Requirements for requlatory purpose regarding to the internal design change control procedure to complete the device design steps.
EVO 700 series high speed handpiece is supplied as non-sterile and can be sterilized by gravity-displacement method, at 132°C for 15 minutes and drying for 30 minutes, and dynamic-air-removal (prevacuum) method, at 134°C for 4 minutes and drying for 15 minutes.
5. Indications for Use:
The EVO 700 series high speed handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations/ restorations. The devices are only for dental handpieces treatment and used by a trained person in the field of dentistry .
6. Substantial Equivalence
Table below provides a comparison of the indications for use and key technological characteristics of EVO 700 series with that of the Primary Predicate, EVO 500 series high speed handpiece (K141183).
| Model | Subject Device | Predicate Device | Comparison
(Same/
Similar/
Different) |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Particular
Intended
use defined
under 21
CFR
872.4200 | TTBIO EVO 700 series
High speed handpiece | TTBIO EVO 500 series
High speed handpiece | Same |
| Intended | Intended to prepare
dental cavities for | Intended to prepare
dental cavities for | |
| use defined | restorations, such as | restorations, such as | |
| under 21 | fillings, and for | fillings, and for | |
| CFR | cleaning teeth. | cleaning teeth. | |
| 872.4200 | | | |
| Indications
for use | The EVO 700 series
High Speed | The EVO 500 series
High Speed | Same |
| for use | Handpieces are | Handpieces are | |
| | designed for removing | designed for removing | |
| | carious material, | carious material, | |
| | reducing hard tooth | reducing hard tooth | |
| | structure, cavity | structure, cavity | |
| | preparation and | preparation and | |
| | finishing tooth
preparations/
restorations. The
devices are only for
dental handpieces
treatment and used by
a trained person in the
field of dentistry. | finishing tooth
preparations/
restorations. The
devices are only for
dental handpieces
treatment and used by
a trained person in the
field of dentistry. | |
| Principle of
operation | The handpiece is
connected to a dental
tubing which delivers
driving air, cooling air
and water to the
cutting bur area.
Optional fiber optics
deliver light to the
cutting area. | The handpiece is
connected to a dental
tubing which delivers
driving air, cooling air
and water to the
cutting bur area.
Optional fiber optics
deliver light to the
cutting area. | Same |
| Device
standard | ISO 14457:2017
ISO 9168:2009 | ISO 14457:2012
ISO 9168:2009 | Similar
(Analysis 1) |
| Rotation
speed
(rpm) | T: 300,000360,000430,000 | T≥300,000
M: 350,000
M≥350,000 | Similar
(Analysis 2) |
| Chuck
system | Push button | Push button | Same |
| Cooling
spray | Multi-spray | Multi-spray | Same |
| Bur
diameter
(mm) | Ø1.591.60 | Ø1.591.60 | Same |
| Bur length
(mm) | T: 192521 | T: 19
M: 162521 | Same |
M: 16
| Drive air
pressure
(bar) | 2.63.0 | 2.63.0 | Same |
| Water
pressure
(bar) | 0.82.0 | 0.82.0 | Same |
| Chip air
pressure
(bar) | 1.03.0 | 1.03.0 | Same |
| Head size
(mm) | T: Ø12.2×H13.55
M: Ø10.5×H12.4 | T: Ø12.2×H13.55
M: Ø10.5×H12.4 | Same |
| Light
system | With or without glass
rod | With or without glass
rod | Same |
5
Image /page/5/Picture/0 description: The image shows the TT BIO logo. The logo consists of two stylized "T" letters, one in blue and the other in green, followed by the word "BIO" in gray. The logo is simple and modern, and the colors are bright and eye-catching.
TTBIO CORP.
2F., NO.7, 6吨 ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL:886-4-23595958 FAX:886-4-23594196
6
Image /page/6/Picture/0 description: The image shows the logo for TR Bio. The logo consists of two stylized "T" shapes, one in blue and one in green, connected to the word "BIO" in gray. The logo is simple and modern, with a clean design.
TTBIO CORP. 2F., NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196
| Materials of body | Light intensity | Bur retention force | |
|---|---|---|---|
| Stainless steel | Approx. 25000 Lux | Up to 24 N-cm | |
| Stainless steel | Approx. 25000 Lux | Up to 24 N-cm | |
| Same | Same | Same |
Substantial Equivalence Discussion
Analysis 1:
The dental handpieces are designed according to FDA recognized consensus standard of device-specific guidance document for dental handpiece, ISO 14457:2017. The update of the guidance or standards did not revise or amend the significant characteristics applicable to EVO 700 series and EVO 500 series high speed handpiece. Therefore, this different technological characteristic does not raise different questions of safety and effectiveness.
Analysis 2:
The FDA recognized consensus standard of device-specific guidance document for dental handpiece, ISO 14457:2017 defines requirement on rotation speed for dental handpiece. According to the standard, the free-running speed of the handpieces shall be within ±10% of that specified in the manufacturer's directions for use, and the given range for rotation speed of EVO 700 series high speed handpiece is within the tolerance of the speed stated on directions for use. Therefore, this different technological characteristic does not raise different questions of safety and effectiveness.
Conclusion
According to the discussion above, the indications for use of subject device, EVO 700 series high speed handpiece is same as predicate device, EVO 500 series high speed handpiece, are identical in the Intended use, Indications for use, Principle of operation, most of the device specifications, and similar, as on the above analysis 1 and 2, in rotation speed (rpm) and complied standards due to the reversion; and, the other differences in nonsignificant characteristics are clarified, the substantial equivalent is claimed. Since the differences of the devices do not raise different questions of safety and effectiveness, EVO 700 series is as safe and effective as legally marketed EVO 500 series.
7. Design Control Activities
The risks arisen from the design modifications activities have been identified and evaluated while controlled through a failure modes and effects analysis
7
Image /page/7/Picture/0 description: The image shows the logo for "T2 BIO". The logo consists of two stylized "T" shapes, one in blue and one in green, followed by the word "BIO" in gray. The "T" shapes are connected at the top, forming a unique design element.
TTBIO CORP. 2F., NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL:886-4-23595958 FAX : 886-4-23594196
(FMEA) that described in FDA-recognized consensus standard, ISO 14971:2019 Medical devices - Application of risk management to medical devices. The safety and effectiveness of EVO 700 series high speed handpiece are also verified and validated according to device-specific, FDA-recognized consensus standard, ISO 14457:2017 Dentistry - Handpieces and motors. The biocompatibility concerns of new material (PEEK) are confirmed by tests determined in ISO 10993-1:2018 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process.
8. Conclusion
Based on the information provided in this premarket notification, the same indications for use with small modifications, EVO 700 series high speed handpiece does not raise different questions of safety and effectiveness and is substantially equivalent to predicate device in terms of safety, effectiveness, and performance.