Mondial Denture Teeth
by Heraeus Kulzer, Inc. 510(k)
Active
510(k) K060994
Overview
The Mondial is a plastic denture tooth designed for use in removable dental prosthetics. Classified as a Class II dental device under FDA regulations, it provides customizable tooth replacements for partial or complete dentures, ensuring functional precision and consistent fit.
Supplied as a reusable, non-sterile component, the Mondial is intended for laboratory processing before incorporation into denture bases. It is regulated under FDA 510(k) clearance (K060994) and adheres to dental-specific manufacturing standards. Available in multiple sizes and shades, it is used in dental laboratories to fabricate dentures with standardized tooth alignment and aesthetic properties.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060994 | Date22 May 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Mondial
- 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
Other devices from Heraeus Kulzer, Inc.
Questions
Are Mondial denture teeth intended for direct patient use, or do they require laboratory processing before fitting into a denture base?
The Mondial denture teeth are designed for laboratory processing only and are not intended for direct patient use. They must be incorporated into denture bases in a dental laboratory to ensure proper alignment, fit, and functionality before being provided to patients.
How are Mondial denture teeth supplied, and what does this mean for their handling and reuse?
Mondial denture teeth are supplied as reusable, non-sterile components. This means they are meant to be processed in a dental laboratory (e.g., cleaned, sterilized, or prepared) before being embedded in denture bases. The non-sterile status indicates they are not pre-sterilized for immediate clinical use and must undergo laboratory procedures prior to patient application.
What range of sizes and shades are available for Mondial denture teeth, and how does this affect customization for patients?
Mondial denture teeth come in multiple sizes and shades, allowing dental laboratories to customize tooth replacements for partial or complete dentures. This variety ensures that the teeth can be matched to a patient’s natural appearance and functional requirements, providing both aesthetic and functional precision.
What regulatory pathway was followed for the Mondial denture teeth, and what does this indicate about their compliance standards?
The Mondial denture teeth were cleared through the FDA’s 510(k) process (K060994) under the Dental advisory committee, classified as a Class II device. This indicates they meet FDA dental-specific manufacturing standards and were determined to be substantially equivalent to a predicate device, ensuring compliance with regulatory requirements for safety and performance.
Are Mondial denture teeth pre-sterilized, or do they require additional processing before use in a denture?
Mondial denture teeth are supplied in a non-sterile state, meaning they are not pre-sterilized for immediate clinical use. They must undergo laboratory processing—such as cleaning, sterilization, or preparation—as part of the denture fabrication process before being embedded in the denture base.