510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021298Substantially Equivalent

Elements Diagnostic Unit

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

K021298 is the FDA 510(k) clearance record for ELEMENTS DIAGNOSTIC UNIT, a class II device, cleared for Sybron Endo/Analytic on under FDA product code EAT (Tester, Pulp). FDA records list 3 510(k) clearances for Sybron Endo/Analytic, from to . As of , FDA records show no recalls naming K021298.

Clearance record

Decision date
Received
(56 days to decision)
Product code
EAT Tester, Pulp
Regulation
21 CFR 872.1720
Device class
Class II
Review panel
Dental
Applicant
Sybron Endo/Analytic 1717 W. Collins Ave., Orange CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EAT

Trailing 12 months

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

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