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Conversil FL and Conversil P

by Wilde-USA, Inc.

510(k) K913583

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 NumberK913583 Date13 Nov 1991ClearedStatusActive

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  • Withdrawn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
ELW
Device Class
Class II
Regulation
21 CFR Part 872.3660
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 dental impression material. It is substantially equivalent to a predicate device and was cleared through the traditional 510(k) pathway.

The device is supplied by Wilde-USA, Inc. and is intended for use in dental settings. It is a Class II medical device with product code ELW and regulation number 872.3660.

Other devices from Wilde-USA, Inc.

See all devices from Wilde-USA, Inc. →

Questions

AI-generated answers, 1 Oct 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 Conversil FL and P dental impression material used for?

    The Conversil FL and P is a dental impression material intended for use in dental settings to create accurate impressions of teeth and oral tissues for various dental procedures.

  • How is the Conversil FL and P dental impression material supplied?

    The device is supplied by Wilde-USA, Inc. and is available as a Class II medical device with product code ELW, though specific packaging details are not provided in the device data.

  • Is the Conversil FL and P dental impression material single-use or reusable?

    The device data does not specify whether the Conversil FL and P dental impression material is designed for single-use or multiple uses, so this information would need to be obtained directly from the manufacturer.

  • What is the regulatory status of the Conversil FL and P dental impression material?

    The Conversil FL and P dental impression material has FDA 510(k) clearance with number K913583, indicating it is substantially equivalent to a predicate device and was cleared through the traditional 510(k) pathway.