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E-Type Adaptor

by Nakanishi Inc.

E-Type 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 04560264573345), active as of 8 Jun 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 8 Jun 2026

Documents

510(k) K081811

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04560264573345 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 04560264573345 listed 1 Jul 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K081811
  2. Listed FDA GUDID 04560264573345

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  • Withdrawn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
E-Type Adaptor
Primary DI / UDI-DI
04560264573345
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)