# K163483: PANA SPRAY Plus

- Pathway: 510(k) (Traditional)
- Applicant: Nakanishi, Inc.
- Decided: Aug 15, 2017 after 246 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K052700 (2005). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131014: Pana Spray Plus, Nsk America Corp. (2013) Summary page 4.

## Most influential descendants
- K170236: Dental Low-speed Turbine Handpiece (2017), 4 descendants of its own
- K181691: High-speed air turbine handpiece / Low-speed air turbine handpiece (2020), 2 descendants of its own
- K220179: High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors (2023), 1 descendant of its own
- K251388: Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) (2026), 0 descendants of its own
- K241074: High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces:  SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces:  SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K163483
Methodology: https://510kreport.com/methodology