VA2-Hp

by Nakanishi Inc.

VA2-Hp is a Class II device made by Nakanishi Inc., cleared under FDA 510(k) K113530 on 31 Jan 2013 and listed in FDA GUDID since 19 Mar 2018 (UDI-DI 04560264556522), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04560264556522 UDI-DI	Date19 Mar 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK113530	Date31 Jan 2013Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04560264556522
FDA 510(k) database 510(k) number K113530

Across registries

2 registries list this device

FDA 510(k) K113530 decided 31 Jan 2013 Active
FDA GUDID UDI-DI 04560264556522 listed 19 Mar 2018 Listed

Timeline

2 dated events

31 Jan 2013 Cleared FDA 510(k) K113530
19 Mar 2018 Listed FDA GUDID 04560264556522

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Ultrasonic dental scaling/debridement system handpiece
Model / reference: VA2-HP

Primary DI / UDI-DI: 04560264556522
510(k) Number: K113530
FDA product code: ELC
GMDN term: Ultrasonic dental scaling/debridement system handpiece

Device class: Class II
Regulation number: 872.4850
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

Other devices from Nakanishi Inc.

Z1102002

Class I
H263018

Class I
Y1500515

Class IIa
CA13190001

Class IIa

See all devices from Nakanishi Inc. →

Properties

Sterilise before use
Prescription use
Serial number
Manufacturing date

Other properties (11, all answered No)