K Number

Device Name

EVO 450 series High Speed Handpieces

Manufacturer

TTBIO CORP.

Date Cleared

2019-12-11

(285 days)

Product Code

EFB

Regulation Number

872.4200

Intended Use

The EVO 450 series is the air-powered dental handpiece which is used by trained dental professionals for removal of carious material, cavities, crown preparations and as a surgical tool for impacted third molar removal and periodontal procedures.

Device Description

The EVO 450 series High Speed Handpieces are similar to other high-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are air-powered handpieces that are reusable, ergonomically shaped, and are provided both with and without a fiber optic light system. Several models could be connected to couplings of manufacturers including TTBIO, KaVo, NSK Mach, Sirona, and Star. Others could be connected to hose connectors type 2 or type 3 according to ISO 9168:2009 Dental handpieces-Hose connectors for air driven dental handpieces. The EVO 450 series High Speed Handpieces will be supplied with water, air and light through the tube and the coupling of a dental treatment unit. For proper operation, make sure that the supply of cooling air is dry, clean and uncontaminated. Make sure that air is not emitted in the direction of the bur. After each patient use, disinfect the tubing waterlines including the handpiece waterlines by flushing with cleaning water to prevent cross-contamination according to handpiece waterlines disinfection procedure of main dental unit.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K141576

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are for a standard air-powered dental handpiece. There is no mention of AI or ML capabilities, image processing, or data sets for training or testing.

Therapeutic

Yes
The device is used to remove carious material, prepare cavities and crowns, and for surgical procedures like third molar removal, which are all intended to treat a disease or injury.

Diagnostic

No
The device is a dental handpiece used for removal of carious material, cavities, crown preparations, and as a surgical tool. These are therapeutic and surgical procedures, not diagnostic ones.

SaMD (Software as a Medical Device)

The device is a physical dental handpiece, which is a hardware device. The description details its mechanical components, power source (air), and connections to dental units, all indicative of a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used directly on a patient for dental procedures (removal of material, preparations, surgical procedures). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
Device Description: The description details a mechanical, air-powered handpiece used for physical manipulation within the mouth. This is consistent with a surgical or procedural tool, not a diagnostic test.
Lack of Diagnostic Function: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information based on laboratory testing.

The device is a surgical/procedural tool used by dental professionals, not a diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

EFB

Device Description

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

trained dental professionals

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 functions of EVO 450 series High Speed Handpieces were verified according to ISO14457:2017. Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of health care products – moist heat – Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices. Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff -Processing/Reprocessing Medical Devices in Health Care Settings.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Maxima PRO2 45L made by Kaltenbach & Voigt GmbH (K141576)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 11, 2019

Ttbio Corp. Shu-Ching Lee Section Chief 2F, No.7, 6th Road Industry Park Taichung, 40755 TAIWAN

Re: K190508

Trade/Device Name: EVO 450 series High Speed Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: November 11, 2019 Received: November 13, 2019

Dear Shu-Ching Lee:

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 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 medical devices and radiation-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 Srinivas Nandkumar, Ph.D. 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

Indications for Use

510(k) Number (if known)

K190508

Device Name EVO 450 series High speed Handpieces

Indications for Use (Describe)

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)

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Image /page/3/Picture/0 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T" letters connected together, followed by the word "BIO" in a simple sans-serif font. The entire logo is in a light gray color. The logo appears to be for a biotechnology company.

TTBIO CORP. 2F, NO.7, 6* ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196

510(K) SUMMARY-K190508

EVO 450 series High Speed Handpieces

1. Date Prepared: December 10,2019

Submitter Information 510(k) Owner: TTBIO CORP. 2F, No.7, 6th Road, Industry Park, Taichung, Taiwan, R.O.C. 40755 Contact Person: Shu-Ching Lee/Section Chief Phone: 886-4-23595958/email: jo@ttbio.com

1. Device Name
  Trade Name: EVO 450 series High Speed Handpieces Common Name: Dental Handpiece Classification Name: Dental Handpiece and Accessories (21 CFR 872.4200, Product Code EFB)
1. Predicate Device: Maxima PRO2 45L made by Kaltenbach & Voigt GmbH (K141576)
1. Device Description:

TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196

Further one there is a nozzle cleaner needle supplied with the EVO 450 series High Speed Handpiece. If spray nozzle is blocked with debris clean the spray nozzle with the nozzle cleaner needle.

1. Intended Use:
  The EVO 450 series is the air-powered dental handpiece which is used by trained dental professionals for removal of carious material, cavities, crown preparations and as a surgical tool for impacted third molar removal and periodontal procedures.
1. Substantial Equivalence
  The EVO 450 series High Speed Handpieces are the same as predicate device, Air-Powered handpieces, which intended for dentistry treatment and these devices are only for trained persons in the field of dentistry. The proposed devices are essentially identical or similar to the predicate device in terms of the design, principles of operation, technological characteristics and materials. The patient contact materials used are well-known biocompatible, so no new issues of biocompatibility are raised with regard to the proposed devices. Additionally, the proposed devices are complying with FDA recognized standards for High-Speed dental handpieces.

Summary Table of Substantial Equivalence
Descriptive
Information	Proposed Device	Predicate Device
	EVO 450 series	Maxima PRO2 45L
(K141576)
Indication for
use	The EVO 450 series is the air-powered
dental handpiece which is used by
trained dental professionals for
removal of carious material, cavities,
crown preparations and as a surgical
tool for impacted third molar removal
and periodontal procedures.	This air-powered dental handpiece is
intended for removal of carious
material, cavities and crow
preparations, removal of filings,
processing of tooth, restoration of
surfaces and as a surgical tool for
third molar removal procedures.
Principle of
operation	The coupling through the tube
connected to a dental unit. The
devices receive the air for the turbine
to proceed the system used
air-powered technique. The cooling
water for cutting treatment. And parts
of devices have a light system for
illumination the operation area.	Through the tube and the coupling
connected to a dental unit, the
air-powered handpiece receives the
air for operating the high speed
turbine, the cooling water for cutting
treatment through one port and light
for illumination the operation area.

Image /page/5/Picture/0 description: The image shows a logo for a company called "TBIO". The logo consists of two stylized "T" shapes that are connected to the word "BIO". The logo is gray and has a modern, minimalist design. The logo is likely used to represent the company's brand and identity.

TTBIO CORP. 2F, NO.7, 6th ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196

Summary Table of Substantial Equivalence
Descriptive
Information	Proposed Device	Predicate Device
	EVO 450 series	Maxima PRO2 45L
(K141576)
Water ports	Four	One
Fiber optics	With and without fiber-optic glass rod
built-in light system	With built-in light system
Light intensity
on input side	N/A	Approx. 25000 Lux
Head
Dimensions	Φ10.5×H12.5mm	Φ12.5×H14.6mm
Type of chuck	Push button locking chuck	Identical
Materials of
body of the
device	Stainless steel	Stainless steel
Bur retention
force	Up to 24 N-cm	Identical
Operation
pressure	2.0-3.0 bar	2.75±0.1 bar
Speed	360,000~440,000 rpm	380,000~420,000 rpm
Conformance with
standards for
shank	Ø1.59mm~1.60 mm	Identical
Head angle	45-degree	Identical
Compliance to
Standards	ISO 14457:2017
ISO 9168:2009	ISO 14457:2012
ISO 9168:2009
Sterilization
Method	Steam Autoclave (Moist Heat)	Steam Autoclave (Moist Heat)
Sterilization
Standard	ISO 17665-1:2006	ISO 17665-1:2006

1. Discussion of non-clinical data:
  The functions of EVO 450 series High Speed Handpieces were verified according to ISO14457:2017. Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of health care products – moist heat – Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices. Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff -Processing/Reprocessing Medical Devices in Health Care Settings.

Image /page/6/Picture/0 description: The image shows the logo for "TT BIO". The logo consists of two stylized "T" shapes that are connected to each other. To the right of the second "T" is the word "BIO" in a simple sans-serif font. The entire logo is in a light gray color.

TTBIO CORP. 2F, NO.7, 6* ROAD INDUSTRY PARK, TAICHUNG, TAIWAN, R.O.C. 40755 TEL : 886-4-23595958 FAX : 886-4-23594196

1. Discussion of Clinical Tests Performed: N/A
1. Conclusion:

The EVO 450 series High Speed Handpieces are substantially equivalent to the predicate device. They are same as the predicate device in terms of its intended use, operating principles and functions.