510(k) · Cleared

Cleared

Pana Spray Plus

K131014510(k) TraditionalCleared Aug 12, 2013123-day reviewClass I21 CFR 872.4200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nsk America Corp. · EFB Handpiece, Air-Powered, Dental

Cleared on Aug 12, 2013 as substantially equivalent to K052700 (Nsk America Corp., 2005) after a 123-day review. Its family tree reaches back 1 generation to 2005. 7 later devices descend from it.

Decided: Aug 12, 2013
Review: 123 days
Class: Class I
Product code: EFB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K052700 (2005). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK052700 Pana-SprayNsk America Corp. · 2005
This deviceK131014 Pana Spray PlusNsk America Corp. · 2013
Descendant · cites it directly · 5 of its ownK163483 PANA SPRAY PlusNakanishi, Inc. · 2017
Descendant · 2 generations on · 4 of its ownK170236 Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
Descendant · 3 generations on · 2 of its ownK181691 High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020
Descendant · 4 generations on · 1 of its ownK220179 High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle…Foshan Coxo Medical Instrument Co., Ltd. · 2023
Descendant · 3 generations on · 0 of its ownK251388 Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4…Foshan Topmed Dental Co., Ltd. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2017high 2 (2017) · low 0 (2018)2026

Most influential descendants

Showing 5 of 7 · See all

K163483PANA SPRAY PlusNakanishi, Inc. · 2017 · cites it directly5descendants
K170236Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · 2 generations on4descendants
K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020 · 3 generations on2descendants
K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsFoshan Coxo Medical Instrument Co., Ltd. · 2023 · 4 generations on1descendant
K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd. · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K052700	Pana-Spray	Nsk America Corp.	2005	—
0 (this device)	K131014	Pana Spray Plus	Nsk America Corp.	2013	—
+1	K163483	PANA SPRAY Plus	Nakanishi, Inc.	2017	—
+2	K170236	Dental Low-speed Turbine Handpiece	Guangdong Jinme Medical Technology Co., Ltd.	2017	—
+3	K181691	High-speed air turbine handpiece / Low-speed air turbine handpiece	Foshan Wenjian Medical Instrument Co., Ltd.	2020	—
+4	K220179	High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle…	Foshan Coxo Medical Instrument Co., Ltd.	2023	—
+3	K251388	Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS…	Foshan Topmed Dental Co., Ltd.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	2	0
2020	1	0
2021	1	0
2023	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K131014, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K052700	Pana-Spray Summary page 1 …Handpiece Lubricant Classification Name: Handpiece, Air-Powered, Dental (21 CER 872.4200, Product Code FMC) Classification: Class I Predicate Device: K052700 NSK America Pana-Spray Device Description: PANA SPRAY Plus is an alcohol-based general handpiece and air-motor lubricant.…	Nsk America Corp.	2005	—

Also cleared against K052700: 2 other devices →

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K163483	PANA SPRAY Plus	Nakanishi, Inc.	2017	5
K202786	Dental Low-speed Handpieces and Accessories	Microp Technology (Taiwan), Inc.	2021	0

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.
Of its descendants, K163483 (Nakanishi, Inc., 2017) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K052700.

How does its category compare?

All EFB devices

EFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · EFB

1in 2025

2007high 12 (2007) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFB

209in 2024

2007high 430 (2022) · low 61 (2007)2026

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

2007high 157 (2022) · low 13 (2007)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	MAUDE reports
2007	12	61	13
2008	7	97	19
2009	11	120	40
2010	8	116	78
2011	4	168	96
2012	8	130	97
2013	3	207	61
2014	7	200	73
2015	7	296	87
2016	3	205	122
2017	7	246	153
2018	3	210	81
2019	3	348	117
2020	5	259	94
2021	2	—	123
2022	5	430	157
2023	4	158	116
2024	5	209	104
2025	1	—	83
2026	4	252	—

What is it indicated for?

PANA SPRAY Plus is a lubricant intended to be used during routine maintenance of dental and medical surgical handpieces after each patient use and prior to sterilization.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131014 · printed Nov 4, 2026

Cite this page

510(k) Report. “K131014: 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/K131014

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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