510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K973539Substantially Equivalent

Roeko Calcium Hydroxide Points

Roeko USA, Inc., Concord MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973539 is the FDA 510(k) clearance record for ROEKO CALCIUM HYDROXIDE POINTS, a class II device, cleared for Roeko USA, Inc. on under FDA product code EJK (Liner, Cavity, Calcium Hydroxide). FDA records list one 510(k) clearance for Roeko USA, Inc. As of , FDA records show no recalls naming K973539.

Clearance record

Decision date
Received
(42 days to decision)
Product code
EJK Liner, Cavity, Calcium Hydroxide
Regulation
21 CFR 872.3250
Device class
Class II
Review panel
Dental
Applicant
Roeko USA, Inc. 100 Main St., Concord MA
510(k) summary
Summary
Third party review
No

Clearances, product code EJK

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