510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K941532Substantially Equivalent

Biocalex 6/9

Bio-Probe, Inc., Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941532 is the FDA 510(k) clearance record for BIOCALEX 6/9, a class II device, cleared for Bio-Probe, Inc. on under FDA product code EJK (Liner, Cavity, Calcium Hydroxide). FDA records list 2 510(k) clearances for Bio-Probe, Inc., from to . As of , FDA records show no recalls naming K941532.

Clearance record

Decision date
Received
(125 days to decision)
Product code
EJK Liner, Cavity, Calcium Hydroxide
Regulation
21 CFR 872.3250
Device class
Class II
Review panel
Dental
Applicant
Bio-Probe, Inc. 5508 Edgewater Dr., Orlando FL
510(k) summary
Statement
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