Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010364969

FEI Number

3010364969

Entity Name

TTBIO CORPORATION

City/State/Country

TAICHUNG, TW

Establishment Address

2F, NO.7, 6TH ROAD INDUSTRY PARK, TAICHUNG 40755, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TTBIO CORPORATION (Owner Number: 10044279)

Owner / Operator Contact Address

2F, NO.7, 6TH ROAD INDUSTRY PARK, TAICHUNG, TW-NOTA 40755, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210832

PMA Number

N/A

All Registered Proprietary Names

Tiger 500, Tiger 500K, Tiger 500N, Tiger 500S, Tiger 500ST Turbo Torque 2400, Turbo Torque 2200 EVO 700K T, EVO 700K TL, EVO 700K M, EVO 700K ML, EVO 700N T, EVO 700N TL, EVO 700N M, EVO 700N ML Vigor S100P, ADVANCED DENTAL, Vigor A67, Choice Pro, A65, S15, C35 Vigor C35, Vigor C2000, Vigor C100, Vigor C25, Vigor C20, Vigor A65, Vigor A68, Vigor S15, Vigor S18 QualityPlus HME001, QualityPlus HST001-1:1, QualityPlus HST001-4:1, QualityPlus HC001, QualityPlus HC001L EVO 450, EVO 450L, EVO 450K, EVO 450KL, EVO 450N, EVO 450NL, EVO 450S, EVO 450SL, EVO 450ST, EVO 450STL EVO 450W, EVO 450WL, EVO 450B, EVO 450BL, EVO 450MW, EVO 450MWL, EVO 450MR, EVO 450MRL EVO 450Y, EVO 450YL, EVO 450 5H, EVO 450 4M EVO 45M4 EVO 450 M4 Tiger 101, Tiger 201, Turbo Torque 1400, Turbo Torque 1200, Choice Pro, Atom QualityPlus PB01P, QualityPlus PB01PF, QualityPlus PB01P9L, QualityPlus PB01P9M ECO 105, ECO 101 4T4, ECO 101 4M4 500T+, 500TL+, 500M+, 500 ML+, 500K T+, 500K TL+, 500K M+, 500K ML+, 500N T+, 500N TL+, 500N M+, 500N ML+ EVO 501K TL, EVO 501K ML, EVO 501N ML, EVO 501N M, EVO 501MW ML, EVO 501ST ML, EVO 501ST M 101 3M4, 101 3T4 Viper 3 17-205, Viper 3 17-195 SABLE ROTAMAX PRO KL, SABLE ROTAMAX PRO NL, SABLE ACCESS PRO KL, SABLE ACCESS PRO NL EZclick-L, EZclick-LED, EZclick-KL, EZclick-KLED, EZclick-NL, EZclick-NLED EZclick, EZclick-K, EZclick-N Turbo Torque 2400, Turbo Torque 2200, Turbo Torque 2200N EVOCLEAN CLEANsert Ultrasonic Insert

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2013-05-20
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2023-08-31
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2020-10-21
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2022-02-16
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2023-11-17
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2021-07-27
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2013-05-20
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2019-12-11
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2013-05-20
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2015-03-09
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2022-05-13

Official Correspondent

Sheng-Chieh Su

US Agent Details

Sheng-Chieh Su Email: gene@thundertiger.com Phone: (949) 5447500

Related Public Records

Same Entity

TTBIO CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06

Similar Registrations

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3014471275	TUNAP GMBH & CO. KG	Wolfratshausen Bavaria, DE
2133714	INTER-MED, INC.	Racine, WI, US
2246821	MTI PRECISION PRODUCTS	Coatesville, PA, US
8010468	GEBR. BRASSELER GMBH & CO. KG	LEMGO North Rhine-Westphalia, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010364969. Last updated year: 2026. Please use registration number 3010364969 when referencing this establishment in official correspondence.