Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list TTBio Corp. with 6 510(k) clearances. The most recent is a 510(k) clearance dated Aug 23, 2023: EVO 700 series high speed handpiece.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Aug 23, 2023 | EVO 700 series high speed handpieceK232243 · EFB | 510(k) clearances |
| Feb 2, 2022 | EVOCLEAN CLEANsert Ultrasonic InsertK210832 · ELC | 510(k) clearances |
| Dec 4, 2020 | TTBIO EVOCLEAN Ultrasonic ScalerK201317 · ELC | 510(k) clearances |
| Dec 11, 2019 | EVO 450 series High Speed HandpiecesK190508 · EFB | 510(k) clearances |
| Feb 27, 2015 | EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECESK141183 · EFB | 510(k) clearances |
| Apr 29, 2014 | ELECTRIC HANDPIECE SYSTEMK132570 · EBW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
