Data / Medical devices / Taiwan / Ttbio Corporation
Ttbio Corporation: FDA-registered device maker in Taichung, Taiwan, 8 510(k) clearances
Ttbio Corporation is registered with the FDA (registration 3010364969) in Taichung, Taiwan. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 23, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010364969
- Address
- 2F, No.7, 6TH Road Industry Park, Taichung, Taiwan, 40755
- Owner or operator
- TTBIO CORPORATION (10044279)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 20, 2013
- Registered through
- 2027
- Brand names listed
- 101 3M4, 101 3T4, 500T+, 500TL+, 500M+, 500 ML+, 500K T+, 500K TL+, 500K M+, 500K ML+, 500N T+, 500N TL+, 500N M+, 500N ML+, ECO 105, ECO 101 4T4, ECO 101 4M4, EVO 450 M4, 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 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Manufacturer | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 23, 2023 | K232243 | EVO 700 series high speed handpiece | EFB | Substantially Equivalent | Ttbio Corp. | accessdata.fda.gov |
| February 2, 2022 | K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | ELC | Substantially Equivalent | Ttbio Corp. | accessdata.fda.gov |
| December 4, 2020 | K201317 | TTBIO EVOCLEAN Ultrasonic Scaler | ELC | Substantially Equivalent | Ttbio Corp. | accessdata.fda.gov |
| December 11, 2019 | K190508 | EVO 450 series High Speed Handpieces | EFB | Substantially Equivalent | Ttbio Corp. | accessdata.fda.gov |
| February 27, 2015 | K141183 | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES | EFB | Substantially Equivalent | Ttbio Corp. | accessdata.fda.gov |
| April 17, 2012 | K112305 | VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES | EGS | Substantially Equivalent | Thunder Tiger Corp. | accessdata.fda.gov |
| April 27, 2011 | K102517 | TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS | EFB | Substantially Equivalent | Thunder Tiger Corp. | accessdata.fda.gov |
| January 20, 2006 | K052822 | DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 | EFB | Substantially Equivalent | Thunder Tiger Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Holder, Film, X-Ray
- All makers of Scaler, Ultrasonic
- All makers of Handpiece, Air-Powered, Dental
- All makers of Mouthpiece, Saliva Ejector
- All makers of Tray, Impression, Preformed
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
Updated August 23, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.