Ttbio Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ttbio Corp.” (first 2014, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 271 days. Since 2017 the median was 242 days, against 258 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 257 |
| 2015 | 1 | 296 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 285 |
| 2020 | 1 | 200 |
| 2021 | 0 | — |
| 2022 | 1 | 320 |
| 2023 | 1 | 26 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ttbio Corp. took a median 242 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 258 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | 3 | 3 |
| ELC | Scaler, Ultrasonic | 2 | 2 |
| EBW | Controller, Foot, Handpiece And Cord | 1 | 1 |
Review panels
- Dental (6)
Most recent Ttbio Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232243 | EVO 700 series high speed handpiece | EFB | 2023-08-23 | 26 |
| K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | ELC | 2022-02-02 | 320 |
| K201317 | TTBIO EVOCLEAN Ultrasonic Scaler | ELC | 2020-12-04 | 200 |
| K190508 | EVO 450 series High Speed Handpieces | EFB | 2019-12-11 | 285 |
| K141183 | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES | EFB | 2015-02-27 | 296 |
| K132570 | ELECTRIC HANDPIECE SYSTEM | EBW | 2014-04-29 | 257 |
Recalls
openFDA lists no recalls under a recalling firm named Ttbio Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ttbio Corp.?
FDA lists 6 510(k) clearances under the applicant name “Ttbio Corp.” (first 2014, latest 2023), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ttbio Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ttbio Corp. is 271 days. Since 2017: 242 days, versus 258 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ttbio Corp.?
The most frequent FDA product codes under this applicant name are EFB (Handpiece, Air-Powered, Dental, 3); ELC (Scaler, Ultrasonic, 2); EBW (Controller, Foot, Handpiece And Cord, 1).
Next steps
- See all 6 Ttbio Corp. clearances with predicates and recalls
- Run predicate analysis for product code EFB, Ttbio Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.