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Modification of Prompt L-Pop

by Espe Dental AG 510(k)

Active United States Open recall

510(k) K992048

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK992048 Date16 Aug 1999ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0797-2025 FDA Class II initiated 26 Nov 2024

    Due to an increase of complaints for bracket bond failures and skin irritation or blistering.

Specification

510(k)

510(k) Number
FDA Product Code
KLE
Device Class
Class II
Regulation
21 CFR Part 872.3200
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 device is a dental bonding agent resin, classified as a Class II medical device under FDA regulation 872.3200. It is a modification of the Prompt L-Pop system, intended for use in dental procedures involving tooth bonding.

It was cleared through the FDA 510(k) process under K992048 on August 16, 1999, and is manufactured by Espe Dental AG in Bavaria, Germany. The device is supplied as a dental resin agent for bonding applications, with no indication of sterility, single-use status, or MRI safety provided in the data.

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Questions

AI-generated answers, 23 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 Modification of Prompt L-Pop dental bonding agent used for?

    The Modification of Prompt L-Pop is a dental bonding agent resin designed for use in dental procedures involving tooth bonding. It is classified as a Class II medical device under FDA regulation 872.3200.

  • Is the Modification of Prompt L-Pop supplied as a sterile product?

    The device data does not indicate whether the Modification of Prompt L-Pop is supplied as a sterile product. No information regarding sterility is provided in the available specifications.

  • Is the Modification of Prompt L-Pop designed for single-use or reuse?

    The available data does not specify whether the Modification of Prompt L-Pop is intended for single-use or reuse. No information regarding its usage status is provided in the device specifications.

  • What regulatory route was used for the clearance of the Modification of Prompt L-Pop?

    The Modification of Prompt L-Pop was cleared through the FDA 510(k) process under K992048 on August 16, 1999, and is classified as a Class II medical device under FDA regulation 872.3200.