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PANA SPRAY Plus

by Nakanishi Inc. 2 variants

PANA SPRAY Plus is a Class I device made by Nakanishi Inc., cleared under FDA 510(k) K163483 on 15 Aug 2017 and listed in FDA GUDID since 24 Sep 2025 (UDI-DI 04589551393367), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K163483

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04589551393367 UDI-DI Date24 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK163483 Date15 Aug 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163483 decided 15 Aug 2017 Active
  • FDA GUDID UDI-DI 04589551393367 listed 24 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163483
  2. Listed FDA GUDID 04589551393367

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Surgical instrument maintenance lubricant
Model / reference
PANA SPRAY Plus
Primary DI / UDI-DI
04589551393367
510(k) Number
FDA product code
EFB
GMDN term
Surgical instrument maintenance lubricant
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K163483)

and 6 more cleared under K163483

Similar devices

Other devices filed under FDA product code EFB (Handpiece, air-powered, dental).

Other devices from Nakanishi Inc.

See all devices from Nakanishi Inc. →

Properties

  • Prescription use
  • Expiration date
Other properties (13, all answered No)