510(k) · Cleared
ClearedPana-Spray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nsk America Corp. · EFB Handpiece, Air-Powered, Dental
Cleared on Dec 20, 2005 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it.
- Decided
- Dec 20, 2005
- Review
- 83 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 3 citing it directly.
- This deviceK052700 Pana-SprayNsk America Corp. · 2005
- Descendant · cites it directly · 7 of its ownK131014 Pana Spray PlusNsk America Corp. · 2013
- Descendant · 2 generations on · 5 of its ownK163483 PANA SPRAY PlusNakanishi, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK170236 Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK113674 Spray & Clean Handpiece Cleaner& Lubricant Maxima Handpiece Cleaner…Handpiece Headquarters, Inc. - Hpr, Inc. · 2012
- Descendant · 4 generations on · 2 of its ownK181691 High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K131014Pana Spray PlusNsk America Corp. · 2013 · cites it directly7descendants
- K163483PANA SPRAY PlusNakanishi, Inc. · 2017 · 2 generations on5descendants
- K170236Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · 3 generations on4descendants
- K113674Spray & Clean Handpiece Cleaner& Lubricant Maxima Handpiece Cleaner & Lubricant Ezcare…Handpiece Headquarters, Inc. - Hpr, Inc. · 2012 · cites it directly3descendants
- K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052700 | Pana-Spray | Nsk America Corp. | 2005 | — |
| +1 | K131014 | Pana Spray Plus | Nsk America Corp. | 2013 | — |
| +2 | K163483 | PANA SPRAY Plus | Nakanishi, Inc. | 2017 | — |
| +3 | K170236 | Dental Low-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017 | — |
| +1 | K113674 | Spray & Clean Handpiece Cleaner& Lubricant Maxima Handpiece Cleaner &… | Handpiece Headquarters, Inc. - Hpr, Inc. | 2012 | — |
| +4 | K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | Foshan Wenjian Medical Instrument Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (13)
See all 133 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?
- Of its descendants, K131014 (Nsk America Corp., 2013) has gone furthest, with 7 descendants of its own.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 new device is a lubricant and is intended for use to lubricate the dental
and medical surgical handpieces.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K052700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052700: Pana-Spray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052700
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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