FDA 510(k) clearance · back to tracker
Glidewell Denture Base Resin
Prismatik Dentalcraft, Inc. cleared K261802 on 2026-08-27, decision: substantially equivalent
K-number
K261802
Sponsor
Prismatik Dentalcraft, Inc.
Device
Glidewell Denture Base Resin
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-08-27
Product code
EBI
Advisory committee
Dental
Medical specialty
Dental
Regulation number
872.3760
Official FDA record
Open K261802on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.