Advanced Denture System
by Advanced Marketing Research Co.
510(k) K780722
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780722 | Date26 May 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- EKO
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3600
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Advanced Denture System is a Denture Preformed (Partially Prefabricated Denture), classified under FDA product code EKO. This device consists of connected preformed teeth designed for use in constructing a custom denture, providing a partially fabricated base for dental professionals to complete the final restoration.
Intended for use in dental offices, the system is supplied as a reusable kit for professional adaptation. It is not sterilised for single-use and requires proper handling and storage per manufacturer guidelines. The device falls under FDA Class II classification, with a 510(k) clearance (K780722) granted under the Dental advisory committee. No MRI safety information or specific sterility assurances are provided in the regulatory data.
Questions
AI-generated answers, 1 Oct 2026
What is the Advanced Denture System used for?
The Advanced Denture System is designed for dental professionals to use in constructing custom dentures. It provides a partially prefabricated base with connected preformed teeth, allowing clinicians to complete the final restoration more efficiently. This kit is specifically intended for use in dental offices to simplify the denture fabrication process.
How is the Advanced Denture System supplied?
The system is supplied as a reusable kit, meaning it is intended for professional adaptation and repeated use in dental offices. It is not pre-sterilized for single-use, so proper handling and storage per manufacturer guidelines are required to maintain its integrity and functionality.
Is the Advanced Denture System sterile?
The device is not sterilized for single-use. It is designed as a reusable kit for dental professionals, so it must be handled and stored according to the manufacturer’s instructions to ensure safety and effectiveness during use.
What are the available models or sizes for the Advanced Denture System?
The Advanced Denture System includes multiple registration numbers (e.g., 3011087996, 3005904906, etc.), which likely correspond to different models or variations of the kit. These variations may cater to different patient needs or dental office preferences. For precise details on specific models, refer to the manufacturer’s documentation or contact their support.
How should the Advanced Denture System be stored?
Since the system is reusable and not pre-sterilized, it must be stored in a clean, dry environment to prevent contamination. Follow the manufacturer’s guidelines for proper storage to ensure the preformed teeth and base remain intact and ready for use. Avoid exposure to moisture, extreme temperatures, or direct sunlight.