FDA Registration Active 🇹🇼 Taiwan

TTBIO CORPORATION

Reg #: 3010364969 · FEI: 3010364969 · Expires 2026
Products
6
Proprietary Names
23
Establishment Types
1
Classifications
6

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Registration Details

Registration Name
TTBIO CORPORATION
Registration Number
3010364969
FEI Number
3010364969
Status
Active
Expiry Year
2026
Initial Importer
No
Address
2F, NO.7, 6TH ROAD INDUSTRY PARK
City
TAICHUNG
Country
TW

Regulatory Submissions

510(k) Number
K102517

Owner / Operator

Firm Name
TTBIO CORPORATION
Operator Number
10044279
Address
2F, NO.7, 6TH ROAD INDUSTRY PARK
City
TAICHUNG
State
TW-NOTA
Postal Code
40755
Country
TW
Correspondent
Sheng-Chieh Su

Products

Device Name Product Code
Handpiece, Air-Powered, Dental EFB
Mouthpiece, Saliva Ejector DYN
Tray, Impression, Preformed EHY
Holder, Film, X-Ray EGZ
Scaler, Ultrasonic ELC
Handpiece, Contra- And Right-Angle Attachment, Dental EGS

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

Establishment Types

Manufacture Medical Device