510(k) · Cleared
ClearedProphy-Mate Neo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nakanishi, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Feb 7, 2012 as substantially equivalent to K032395 (Nakanishi, Inc., 2003) and 2 other predicates after a 146-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Feb 7, 2012
- Review
- 146 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K900709 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 2 generations backK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- 1 generation backK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- This deviceK112673 Prophy-Mate NeoNakanishi, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| −2 | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| −1 | K022119 | Ems Air-Flow Handy 2 Dental Handpiece | Electro Medical Systems SA | 2002 | — |
| 0 (this device) | K112673 | Prophy-Mate Neo | Nakanishi, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 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? (3)
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 |
|---|---|---|---|
| * | K032395 | Prophy-MateSummary page 1…ed Tooth Polishing System Classification Name: EFB3 872.4200 Handpiece, Air-Powered, Dental Predicate Device: K032395 - Prophy-Mate K973876 - Propbyflex2, Model 2012… | 2003 |
| * | K973876 | Prophyflex 2, Model 2012Summary page 1…EFB3 872.4200 Handpiece, Air-Powered, Dental Predicate Device: K032395 - Prophy-Mate K973876 - Propbyflex2, Model 2012 K022 119 - EMS AIR-FLOW® handy 2 Device Descript… | 1997 |
| * | K022119 | Ems Air-Flow Handy 2 Dental HandpieceSummary page 1…Predicate Device: K032395 - Prophy-Mate K973876 - Propbyflex2, Model 2012 K022 119 - EMS AIR-FLOW® handy 2 Device Description: The Prophy-Mate neo is an air-powered tooth polishing system.… | 2002 |
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?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 9.5 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K032395.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Prophy-Mate Nec device is intended for use in dental applications to remove stains and
plaque depositsfrom the teeth by shooting a mixture of sodium bicarbonatepowders or calcium
carbonatepowders, air, and water onto tooth surfaces.
The Prophy-Mate neo can also be used in dental applications to prepare surface prior to
bonding and to preparefor pit andfissure sealant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112673: Prophy-Mate Neo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112673
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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