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SMARTJET BONE GRAFT LIQUID APPLICATOR - Sk

by Harvest Technologies, Corp.

510(k) K011032

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 NumberK011032 Date3 Jul 2001ClearedStatusActive

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  • Withdrawn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
LYC
Models / Variants
Sk
S
Device Class
Class II
Regulation
21 CFR Part 872.3930
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

This device is a bone grafting material applicator designed for the delivery of liquid bone graft materials. It is classified as a Bone Grafting Material, Synthetic under FDA regulation 872.3930 and product code LYC.

The device received FDA 510(k) clearance K011032 on July 3, 2001, as substantially equivalent to a predicate device. It is manufactured by Harvest Technologies, Corp. and is intended for use in dental applications as indicated by the advisory committee classification.

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Questions

AI-generated answers, 21 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 SMARTJET Bone Graft Liquid Applicator used for?

    This device is designed for the delivery of liquid bone graft materials in dental applications, as indicated by its FDA classification under product code LYC and advisory committee classification for dental use.

  • How is the SMARTJET Bone Graft Liquid Applicator supplied?

    The device is supplied as a bone grafting material applicator with a spray tip and dual lumen cannula configuration, model SK/S, intended for use with liquid bone graft materials in clinical settings.

  • Is the SMARTJET Bone Graft Liquid Applicator sterile or single-use?

    The device data does not specify sterility or single-use/reuse status; therefore, no claim can be made about its sterility or reusability based solely on the provided information.

  • What regulatory pathway was used for the SMARTJET Bone Graft Liquid Applicator?

    The device received FDA 510(k) clearance K011032 on July 3, 2001, as substantially equivalent to a predicate device, classified under FDA regulation 872.3930 and product code LYC for bone grafting material, synthetic.