510(k) · Cleared
ClearedEVO 700 series high speed handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ttbio Corp. · EFB Handpiece, Air-Powered, Dental
Cleared on Aug 23, 2023 as substantially equivalent to K141183 (Ttbio Corp., 2015) after a 26-day review. Its family tree reaches back 1 generation to 2015.
- Decided
- Aug 23, 2023
- Review
- 26 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K141183 (2015). No later device cites it as a predicate yet.
- Root · 1 generation backK141183 Evo 500 Series High Speed Handpieces/Tiger 500/300/101 Series High…Ttbio Corp. · 2015
- This deviceK232243 EVO 700 series high speed handpieceTtbio Corp. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K141183 | Evo 500 Series High Speed Handpieces/Tiger 500/300/101 Series High Speed… | Ttbio Corp. | 2015 | — |
| 0 (this device) | K232243 | EVO 700 series high speed handpiece | Ttbio Corp. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EFB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141183 | Evo 500 Series High Speed Handpieces/Tiger 500/300/101 Series High Speed HandpiecesSummary page 4…EFB Common Name Handpiece 3. Predicate Device Proprietary Name EVO 500 series High Speed Handpiece Premarket Notification K141183 Regulation Number 21 CFR 872.4200 Regulation Name Dental handpiece and accessories Regulatory C… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
What is it indicated for?
The EVO 700 series High Speed Handpieces are designed for removing carious material, reducing hard tooth structure, cavity preparation and finishing tooth preparations/ restorations. The devices are only for dental handpieces treatment and used by a trained person in the field of dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232243: EVO 700 series high speed handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232243
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026