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Kava and Kava with Herbst

by Sketchpad Innovations, LLC

510(k) K182661

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182661 Date13 Feb 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LRK
Device Class
Class II
Regulation
21 CFR Part 872.5570
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Kava and Kava with Herbst is a Class 2 dental device manufactured by Sketchpad Innovations, LLC. It is designed for anti-snoring purposes and is part of the LRK product code category.

The device is supplied as a single-use or reusable product, though specific sterility information is not provided. It received FDA 510(k) clearance on February 13, 2019, under approval number K182661, and is regulated under product code LRK.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Kava and Kava with Herbst device used for?

    The Kava and Kava with Herbst is a Class 2 dental device specifically designed for anti-snoring purposes. It is manufactured by Sketchpad Innovations, LLC and falls under the LRK product code category.

  • Is the Kava device single-use or reusable?

    The Kava and Kava with Herbst device is supplied as either a single-use or reusable product, though specific sterility information is not provided in the available documentation.

  • What regulatory approval does the Kava device have?

    The Kava and Kava with Herbst device received FDA 510(k) clearance on February 13, 2019, under approval number K182661. It is regulated under product code LRK and is classified as a Class 2 dental device.

  • What sizes or models of the Kava device are available?

    The available information does not specify different sizes or models of the Kava and Kava with Herbst device. The documentation only mentions the device name without detailing variations in size or model options.