510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K010219Substantially Equivalent

Challenger Direct Composite

International Dental Research, Ayer MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010219 is the FDA 510(k) clearance record for CHALLENGER DIRECT COMPOSITE, a class II device, cleared for International Dental Research on under FDA product code EBF (Material, Tooth Shade, Resin). FDA records list one 510(k) clearance for International Dental Research. As of , FDA records show no recalls naming K010219.

Clearance record

Decision date
Received
(28 days to decision)
Product code
EBF Material, Tooth Shade, Resin
Regulation
21 CFR 872.3690
Device class
Class II
Review panel
Dental
Applicant
International Dental Research 5 Whitcomb Ave., Ayer MA
510(k) summary
Summary
Third party review
No

Clearances, product code EBF

Trailing 12 months
19 clearances under product code EBF in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code EBF, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20260
March 20262
April 20265
May 20262
June 20262
July 20262
August 20261
September 20262
October 20260