Myerson's Economy Denture Base Material
510(k) K970522
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK970522 | Date14 May 1997 | 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- Withdrawn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
- EBI
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Resin, Denture, Relining, Repairing, Rebasing material, classified under FDA product code EBI. It is designed as a base material for constructing full and partial dentures, providing a durable foundation for prosthetic dental restorations. The material is intended for use in dental laboratories during the fabrication process, ensuring proper fit and function of dentures.
Supplied as a dental resin, this material is intended for single-use applications in denture fabrication, including relining, repairing, and rebasing procedures. It is regulated under FDA 510(k) clearance (K970522) as a Class 2 device, with a decision date of May 14, 1997. The material is not sterile and must be handled in a controlled dental laboratory environment. No additional regulatory status beyond the stated 510(k) clearance is implied.
Other devices from Austenal, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is Myerson’s Economy Denture Base Material used for?
This resin is designed specifically for constructing full and partial dentures as a base material in dental laboratories. It serves as a durable foundation during fabrication, ensuring proper fit and function of prosthetic dental restorations. It is also suitable for relining, repairing, and rebasing existing dentures, providing flexibility in clinical adjustments.
Is this material sterile, and how should it be handled?
Myerson’s Economy Denture Base Material is not sterile and must be handled in a controlled dental laboratory environment. Since it is intended for single-use in denture fabrication, it should be stored in a clean, dry area away from direct sunlight or extreme temperatures. Always follow standard dental laboratory protocols for material preparation and use.
Is this resin reusable or intended for single-use?
This material is explicitly supplied for single-use applications in denture fabrication, relining, repairing, and rebasing procedures. It is not designed for repeated use or reprocessing, as this could compromise its structural integrity and safety for patient use.
What regulatory clearance does this denture base material have?
Myerson’s Economy Denture Base Material holds FDA 510(k) clearance (K970522) as a Class II device, classified under product code EBI. The clearance was granted on May 14, 1997, following a determination of substantial equivalence to a predicate device. No additional regulatory status beyond this clearance is implied.
What sizes or models are available for this denture base material?
The provided specifications do not detail specific sizes or model variants for this resin. However, as a general-purpose denture base material, it is typically supplied in bulk or standard laboratory quantities to accommodate various denture fabrication needs. For precise quantities or packaging, refer to the manufacturer’s technical data sheet or contact Austenal, Inc.