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Sr-Ivocap Plus

by Ivoclar North America, Inc.

510(k) K915377

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 NumberK915377 Date31 Jan 1992ClearedStatusActive

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  • Withdrawn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
EBI
Device Class
Class II
Regulation
21 CFR Part 872.3760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 SR-IVOCAP PLUS is a resin used for denture relining, repairing, and rebasing. It is classified under product code EBI and is intended for dental applications.

This device received FDA 510(k) clearance under number K915377 on January 31, 1992, and was found substantially equivalent to a predicate device. It is manufactured by Ivoclar North America, Inc. and is regulated as a Class II medical device.

Other devices from Ivoclar North America, Inc.

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Questions

AI-generated answers, 24 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 SR-IVOCAP PLUS used for?

    The SR-IVOCAP PLUS is a resin used for denture relining, repairing, and rebasing. It is intended for dental applications, specifically to restore the fit and function of dentures by adding new material to the tissue-bearing surface.

  • How is the SR-IVOCAP PLUS supplied and is it sterile?

    The device data does not specify the supply format or sterility status of the SR-IVOCAP PLUS. As a denture reline resin, it is typically supplied in a non-sterile, mixed-paste or powder-liquid system for chairside or laboratory use, but this detail is not provided in the source information.

  • Is the SR-IVOCAP PLUS a single-use or reusable device?

    The SR-IVOCAP PLUS is a resin material used in denture procedures, not a reusable instrument. Once mixed and applied, it is intended for single-patient use during the relining, repairing, or rebasing process and is not designed for reuse after curing.

  • What sizes or models are available for the SR-IVOCAP PLUS?

    The device data does not list specific sizes, models, or reference numbers for the SR-IVOCAP PLUS beyond its name and product code EBI. No variations or configurations are described in the provided information.

  • How should the SR-IVOCAP PLUS be stored?

    Storage conditions for the SR-IVOCAP PLUS are not specified in the device data. Users should refer to the manufacturer’s labeling for proper storage instructions, which typically involve keeping resin components in a cool, dry place away from direct sunlight and extreme temperatures.