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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2013-05-20 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2020-10-21 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2022-02-16 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2023-11-17 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2021-07-27 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2013-05-20 |
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