Manufacturer registered with FDA
Ttbio Corp.
TAICHUNG, Taiwan. Lists 6 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 24
- 510(k) clearances
- 62014–2023
- Markets registered in
- 44 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Ttbio Corp. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Ttbio Corp. | 6 clearances | 2014–2023 | Below |
| European Union | EUDAMED | Manufacturer | TTBIO CORP. | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | TTBIO Corp | 1 | 2014–2014 | Pure Global AI |
| South Korea | MFDS | Manufacturer | TTBIO Corp. | 1 | 2007–2007 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Ttbio Corp. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | ECO 105, ECO 101 4T4, ECO 101 4M4EVO 450 M4EVO 450, EVO 450L, EVO 450K, EVO 450KL, EVO 450N, EVO 450NL, EVO 450S, EVO 450SL, EVO 450ST, EVO 450STLEVO 450W, EVO 450WL, EVO 450B, EVO 450BL, EVO 450MW, EVO 450MWL, EVO 450MR, EVO 450MRLEVO 450Y, EVO 450YL, EVO 450 5H, EVO 450 4MEVO 45M4EVO 501K TL, EVO 501K ML, EVO 501N ML, EVO 501N M, EVO 501MW ML, EVO 501ST ML, EVO 501ST MEVO 700K T, EVO 700K TL, EVO 700K M, EVO 700K ML, EVO 700N T, EVO 700N TL, EVO 700N M, EVO 700N MLEZclick-L, EZclick-LED, EZclick-KL, EZclick-KLED, EZclick-NL, EZclick-NLEDEZclick, EZclick-K, EZclick-N 10 moreHandpiece Maintenance MachineQualityPlus PB01P, QualityPlus PB01PF, QualityPlus PB01P9L, QualityPlus PB01P9MSABLE ROTAMAX PRO KL, SABLE ROTAMAX PRO NL, SABLE ACCESS PRO KL, SABLE ACCESS PRO NLTiger 101, Tiger 201, Turbo Torque 1400, Turbo Torque 1200, Choice Pro, AtomTiger 500, Tiger 500K, Tiger 500N, Tiger 500S, Tiger 500STTurbo Torque 2400, Turbo Torque 2200Turbo Torque 2400, Turbo Torque 2200, Turbo Torque 2200NViper 3 17-205, Viper 3 17-195101 3M4, 101 3T4500T+, 500TL+, 500M+, 500 ML+, 500K T+, 500K TL+, 500K M+, 500K ML+, 500N T+, 500N TL+, 500N M+, 500N ML+ | 2013 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | EVOCLEAN CLEANsert Ultrasonic Insert | 2021 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | — | 2020 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | QualityPlus HME001, QualityPlus HST001-1:1, QualityPlus HST001-4:1, QualityPlus HC001, QualityPlus HC001LVigor C35, Vigor C2000, Vigor C100, Vigor C25, Vigor C20, Vigor A65, Vigor A68, Vigor S15, Vigor S18Vigor S100P, ADVANCED DENTAL, Vigor A67, Choice Pro, A65, S15, C35 | 2013 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | — | 2023 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | — | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Ttbio Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Aug 2023 | K232243 | EVO 700 series high speed handpiece | EFB Dental Air-Powered Handpiece |
| 2 Feb 2022 | K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | ELC Ultrasonic Scaler |
| 4 Dec 2020 | K201317 | TTBIO EVOCLEAN Ultrasonic Scaler | ELC Ultrasonic Scaler |
| 11 Dec 2019 | K190508 | EVO 450 series High Speed Handpieces | EFB Dental Air-Powered Handpiece |
| 27 Feb 2015 | K141183 | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES | EFB Dental Air-Powered Handpiece |
| 29 Apr 2014 | K132570 | ELECTRIC HANDPIECE SYSTEM | EBW Handpiece and Cord Foot Controller |
Some of these clearances are listed with FDA today by another company: Peter Brasseler Holdings, LLC (2), Nordent MFG., Inc. (1).
Also lists devices cleared under other names
Ttbio Corp. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Thunder Tiger Corp. (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Apr 2012 | K112305 | VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES | Thunder Tiger Corp. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 27 Apr 2011 | K102517 | TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS | Thunder Tiger Corp. | EFB Dental Air-Powered Handpiece |
| 20 Jan 2006 | K052822 | DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202 | Thunder Tiger Corp. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TTBIO CORPORATIONFDA reg. 3010364969 | TAICHUNG, Taiwan | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044279). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.