> ## Content Index
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# Guide on Denture Resin Performance Criteria
- URL: https://www.fdaweb.com/guide-on-denture-resin-performance-criteria/
- Published: 2021-08-27T12:00:00.000Z
- Updated: 2026-09-14T17:12:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150032

FDA has posted a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/denture-base-resins-performance-criteria-safety-and-performance-based-pathway?ref=fdaweb.com) entitled *Denture Base Resins — Performance Criteria for Safety and Performance Based Pathway*. The document provides performance criteria for denture base resins for those using the pathway to market. Under the framework, 510(k) submitters have the option to use the performance criteria proposed in the guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.