510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790339Substantially Equivalent

Concept II

Richardson Merrel, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K790339 is the FDA 510(k) clearance record for CONCEPT II, a class II device, cleared for Richardson Merrel, Inc. on under FDA product code EBE (Coating, Denture Hydrophilic, Resin). FDA records list 2 510(k) clearances for Richardson Merrel, Inc., from to . As of , FDA records show no recalls naming K790339.

Clearance record

Decision date
Received
(146 days to decision)
Product code
EBE Coating, Denture Hydrophilic, Resin
Regulation
21 CFR 872.3300
Device class
Class II
Review panel
Dental
Applicant
Richardson Merrel, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EBE

Trailing 12 months

FDA records hold no clearances under product code EBE in the trailing twelve months.

FDA records show no clearances under product code EBE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EBE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260