510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K984037Substantially Equivalent

Core-IDE

Roydent Dental Products, Inc., Rochester Hills MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984037 is the FDA 510(k) clearance record for CORE-IDE, a class II device, cleared for Roydent Dental Products, Inc. on under FDA product code EBD (Coating, Filling Material, Resin). FDA records list 3 510(k) clearances for Roydent Dental Products, Inc., from to . As of , FDA records show no recalls naming K984037.

Clearance record

Decision date
Received
(84 days to decision)
Product code
EBD Coating, Filling Material, Resin
Regulation
21 CFR 872.3310
Device class
Class II
Review panel
Dental
Applicant
Roydent Dental Products, Inc. 1010 W. Hamlin Rd., Rochester Hills MI
510(k) summary
Summary
Third party review
No

Clearances, product code EBD

Trailing 12 months
1 clearance under product code EBD in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260