510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013993Substantially Equivalent

Neocalex

Stephen M Koral, Dmd, Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013993 is the FDA 510(k) clearance record for NEOCALEX, a class I device, cleared for Stephen M Koral, Dmd on under FDA product code EIK (Carver, Wax, Dental). FDA records list 2 510(k) clearances for Stephen M Koral, Dmd, from to . As of , FDA records show no recalls naming K013993.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EIK Carver, Wax, Dental
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Stephen M Koral, Dmd 2006 Broadway, Boulder CO
510(k) summary
Statement
Third party review
No

Clearances, product code EIK

Trailing 12 months

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

FDA records show no clearances under product code EIK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EIK, 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