510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K926406Substantially Equivalent

Dual Cure Reline Material

Dentsply Intl., York PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926406 is the FDA 510(k) clearance record for DUAL CURE RELINE MATERIAL, a class II device, cleared for Dentsply Intl. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 291 510(k) clearances for Dentsply Intl., from to . As of , FDA records show no recalls naming K926406.

Clearance record

Decision date
Received
(100 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Dentsply Intl. 570 W. College Ave., York PA
510(k) summary
Summary
Third party review
No

Clearances, product code EBI

Trailing 12 months
7 clearances under product code EBI in the twelve months to November 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260
November 20260