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BA-Adaptor

by Nakanishi Inc. 2 variants

BA-Adaptor is a Class I device made by Nakanishi Inc., cleared under FDA 510(k) K081811 on 21 Jan 2009 and listed in FDA GUDID since 1 Jul 2020 (UDI-DI 04560264573406), active as of 21 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 21 Oct 2026

Documents

510(k) K081811

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04560264573406 UDI-DI Date1 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK081811 Date21 Jan 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K081811 decided 21 Jan 2009 Active
  • FDA GUDID UDI-DI 04560264573406 listed 1 Jul 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081811
  2. Listed FDA GUDID 04560264573406

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Dental handpiece maintenance unit
Model / reference
BA-Adaptor
Primary DI / UDI-DI
04560264573406
510(k) Number
FDA product code
EFB
GMDN term
Dental handpiece maintenance unit
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental handpiece maintenance unit

Cleared under the same submission (K081811)

and 8 more cleared under K081811

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
  • Lot / batch number
Other properties (13, all answered No)