510(k) · Cleared
ClearedPANA SPRAY Plus
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 Aug 15, 2017 as substantially equivalent to K131014 (Nsk America Corp., 2013) after a 246-day review. Its family tree reaches back 2 generations to 2005. 5 later devices descend from it.
- Decided
- Aug 15, 2017
- Review
- 246 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K052700 (2005). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK052700 Pana-SprayNsk America Corp. · 2005
- 1 generation backK131014 Pana Spray PlusNsk America Corp. · 2013
- This deviceK163483 PANA SPRAY PlusNakanishi, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK170236 Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK181691 High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK220179 High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle…Foshan Coxo Medical Instrument Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK251388 Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4…Foshan Topmed Dental Co., Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK241074 High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19…Foshan Soco Precision Instrument Co., Ltd. · 2024
Most influential descendants
Showing 5 of 5 · See all- K170236Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · cites it directly4descendants
- K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020 · 2 generations on2descendants
- K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsFoshan Coxo Medical Instrument Co., Ltd. · 2023 · 3 generations on1descendant
- K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd. · 2026 · 2 generations on0descendants
- K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low…Foshan Soco Precision Instrument Co., Ltd. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K052700 | Pana-Spray | Nsk America Corp. | 2005 | — |
| −1 | K131014 | Pana Spray Plus | Nsk America Corp. | 2013 | — |
| 0 (this device) | K163483 | PANA SPRAY Plus | Nakanishi, Inc. | 2017 | — |
| +1 | K170236 | Dental Low-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | 2017 | — |
| +2 | K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | Foshan Wenjian Medical Instrument Co., Ltd. | 2020 | — |
| +3 | K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle… | Foshan Coxo Medical Instrument Co., Ltd. | 2023 | — |
| +2 | K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS… | Foshan Topmed Dental Co., Ltd. | 2026 | — |
| +4 | K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22)… | Foshan Soco Precision Instrument Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K131014 | Pana Spray PlusSummary page 4…Dental handpieces and accessories Classification Handpiece, air-powered, dental Name: Product Code: EFB Class 1 872.4200 Predicate PRIMARY: K131014 - NAKANISHI, INC. PANA SPRAY Plus Devices: REFERENCE: K113674 - Handpiece Headquarters Inc, - HPR Inc.… | 2013 |
| † | K113674 | Spray & Clean Handpiece Cleaner& Lubricant Maxima Handpiece Cleaner & Lubricant Ezcare… | 2012 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170236 | Dental Low-speed Turbine Handpiece | 2017 | 4 |
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 12 years and passes through 2 companies; a new generation was cleared every 7.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K170236 (Guangdong Jinme Medical Technology Co., Ltd., 2017) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K131014.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
PANA SPRAY Plus is a lubricant to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization and is intended for use to clean and lubricate the dental and medical surgical handpieces.
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/K163483 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163483: PANA SPRAY Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163483
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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