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SPRYTIE - ST003

by Russell B. Walther

510(k) K092530

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092530 Date2 Apr 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DZK
Models / Variants
ST003
Device Class
Class II
Regulation
21 CFR Part 872.4880
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Sprytie is an intraosseous fixation wire used in dental procedures. It is designed to provide stabilization and support in bone structures during dental interventions.

The device is supplied in models ST001, ST002, and ST003, and is classified as a Class II medical device. It is regulated under 21CFR 872.4880 and received FDA 510(k) clearance in 2010 with the K092530 number.

Questions

AI-generated answers, 19 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 Sprytie device used for in dental procedures?

    The Sprytie is an intraosseous fixation wire designed to provide stabilization and support in bone structures during dental interventions.

  • What models are available for the Sprytie device?

    The Sprytie is supplied in three models: ST001, ST002, and ST003, each designed for specific dental applications requiring intraosseous fixation.

  • Is the Sprytie device single-use or reusable?

    The device information does not specify whether the Sprytie is single-use or reusable, so users should consult the manufacturer's instructions for proper handling and disposal.

  • How is the Sprytie device classified in terms of regulatory status?

    The Sprytie is classified as a Class II medical device and received FDA 510(k) clearance in 2010 with the K092530 number, indicating it meets safety and effectiveness requirements.