Skip to content

Condylaform II NFC

by Ivoclar Vivadent, Inc.

510(k) K060565

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 NumberK060565 Date8 May 2006ClearedStatusActive

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  • Withdrawn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
ELM
Device class
Class II
Regulation
21 CFR Part 872.3590
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.

The Condylaform II NFC is a dental device classified as a Denture, Plastic, Teeth (per FDA classification 872.3590). It is designed as a customizable base material for fabricating removable partial dentures, providing a resilient and adaptable foundation for prosthetic teeth. The device is engineered to accommodate the anatomical contours of the oral cavity, ensuring proper fit and function for patients requiring partial denture solutions. Its composition and form allow for precise molding to individual patient anatomy, enhancing stability and comfort during use.

Condylaform II NFC is supplied as a reusable, non-sterile dental material intended for use in dental laboratories. It is processed under controlled conditions to achieve the required physical properties for denture fabrication. The material is compatible with standard dental laboratory procedures and is intended for single-patient use after customization. No specific MRI safety information is provided, and the device requires proper storage in a clean, dry environment to maintain its integrity. The product holds FDA 510(k) clearance (K060565) under the Traditional 510(k) review pathway, with a classification as a Class II device.

Other devices from Ivoclar Vivadent, Inc.

See all devices from Ivoclar Vivadent, 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 Condylaform II NFC used for?

    The Condylaform II NFC is a customizable plastic base material specifically designed for fabricating removable partial dentures. Its flexible and adaptable composition allows it to conform to the unique anatomical contours of a patient’s oral cavity, ensuring a secure and comfortable fit. This makes it ideal for patients requiring partial denture solutions where stability and comfort are critical.

  • How is the Condylaform II NFC supplied and prepared for use?

    The Condylaform II NFC is supplied as a reusable, non-sterile dental material intended exclusively for use in dental laboratories. It must be processed under controlled conditions to achieve the required physical properties for denture fabrication. Once customized to fit a specific patient’s anatomy, it is intended for single-patient use only, adhering to standard dental laboratory procedures.

  • Is the Condylaform II NFC sterile or single-use?

    The Condylaform II NFC is non-sterile as supplied and is designed for single-patient use after customization. It is not pre-sterilized and must be processed in a laboratory setting before use. This ensures that each patient receives a tailored, non-sterile material that is dedicated to their specific denture requirements.

  • How should the Condylaform II NFC be stored?

    The Condylaform II NFC requires storage in a clean, dry environment to maintain its integrity and usability. Proper storage conditions prevent contamination and degradation of the material, ensuring it remains suitable for processing in dental laboratories. Always follow manufacturer guidelines for handling and storage to preserve its properties.

  • Does the Condylaform II NFC have any specific safety considerations?

    The Condylaform II NFC does not provide specific MRI safety information, meaning its compatibility with MRI procedures has not been evaluated or documented. Clinicians should exercise caution when considering MRI scans for patients with dentures made from this material. Additionally, the material is not pre-sterilized, so proper laboratory processing and single-patient use protocols must be followed.