510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K031664Substantially Equivalent

Elements Obturation Unit

Sybron Endo/Analytic, Redmond WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031664 is the FDA 510(k) clearance record for ELEMENTS OBTURATION UNIT, a class I device, cleared for Sybron Endo/Analytic on under FDA product code EKR (Plugger, Root Canal, Endodontic). FDA records list 3 510(k) clearances for Sybron Endo/Analytic, from to . As of , FDA records show 3 recalls naming K031664.

Clearance record

Decision date
Received
(335 days to decision)
Product code
EKR Plugger, Root Canal, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Sybron Endo/Analytic 15233 NE 90th St., Redmond WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EKR

Trailing 12 months

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

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