510(k) · Cleared
ClearedMaxima PRO 45L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kavo DO Brasil Industria E Comercio Ltda · EFB Handpiece, Air-Powered, Dental
Cleared on May 4, 2015 as substantially equivalent to K112024 (Nakanishi, Inc., 2012) and 1 other predicate after a 326-day review. Its family tree reaches back 6 generations to 1995. 3 later devices descend from it.
- Decided
- May 4, 2015
- Review
- 326 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K935676 (1995). 12 ancestors in all, the oldest K760794 (1976). 3 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
- 5 generations backK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
- 4 generations backK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
- 3 generations backK062740 Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006
- 2 generations backK101717 Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam…Aerobine, Inc. · 2010
- 1 generation backK112024 TI-Max X450Nakanishi, Inc. · 2012
- This deviceK141576 Maxima PRO 45LKavo DO Brasil Industria E Comercio Ltda · 2015
- Descendant · cites it directly · 0 of its ownK221741 TRAUS Air Dental HandpieceSaeshin Precision Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK202371 Highspeed Airturbine HandpieceBeijing Dongbo Dental Handpiece Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK190508 EVO 450 series High Speed HandpiecesTtbio Corp. · 2019
Most influential descendants
Showing 3 of 3 · See all- K221741TRAUS Air Dental HandpieceSaeshin Precision Co., Ltd. · 2023 · cites it directly0descendants
- K202371Highspeed Airturbine HandpieceBeijing Dongbo Dental Handpiece Co., Ltd. · 2021 · cites it directly0descendants
- K190508EVO 450 series High Speed HandpiecesTtbio Corp. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935676 | Micro RSH High Speed Handpiece | Micro Motors, Inc. | 1995 | — |
| −5 | K033213 | Codent Dental Air-Powered Handpiece, Model HPS | Codent Technical Industry Co., Ltd. | 2004 | — |
| −4 | K052822 | Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202 | Thunder Tiger Corp. | 2006 | — |
| −3 | K062740 | Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU | Jindell Medical Instruments Co., Ltd. | 2006 | — |
| −2 | K101717 | Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor… | Aerobine, Inc. | 2010 | — |
| −1 | K112024 | TI-Max X450 | Nakanishi, Inc. | 2012 | — |
| 0 (this device) | K141576 | Maxima PRO 45L | Kavo DO Brasil Industria E Comercio Ltda | 2015 | — |
| +1 | K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | 2023 | — |
| +1 | K202371 | Highspeed Airturbine Handpiece | Beijing Dongbo Dental Handpiece Co., Ltd. | 2021 | — |
| +1 | K190508 | EVO 450 series High Speed Handpieces | Ttbio Corp. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K112024 | TI-Max X450Summary page 5…§ 872.4200 • Product Code and Classification – EFB, Class I Devices for Which Substantial Equivalence is Claimed: • HIGH SPEED AIR TURBINE HANDPIECES TI Max X 450 (K112024) marketed by Nakanishi, Incorporated • HIGH SPEED AIR TURBINE HANDPIECES Karan 45, Dexor 45 (K101717) marketed by Aerobine, Incor… | 2012 |
| * | K101717 | Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor 45; Karam 4H…Summary page 5…lence is Claimed: • HIGH SPEED AIR TURBINE HANDPIECES TI Max X 450 (K112024) marketed by Nakanishi, Incorporated • HIGH SPEED AIR TURBINE HANDPIECES Karan 45, Dexor 45 (K101717) marketed by Aerobine, Incorporated Device Description: The Maxima PRO 45L air-driven handpieces are air driven dental handpie… | 2010 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K221741 (Saeshin Precision Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K112024.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
This air-powered dental handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures.
It is designed for use by a trained professional in the field of general dentistry.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141576 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141576: Maxima PRO 45L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141576
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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