510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973548Substantially Equivalent

Mercury Dental

Aleaciones Dentales Zeyco, S.A. de C.V., Guadalajara, MX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973548 is the FDA 510(k) clearance record for MERCURY DENTAL, a class II device, cleared for Aleaciones Dentales Zeyco, S.A. DE C.V. on under FDA product code ELY (Mercury). FDA records list one 510(k) clearance for Aleaciones Dentales Zeyco, S.A. DE C.V. As of , FDA records show no recalls naming K973548.

Clearance record

Decision date
Received
(186 days to decision)
Product code
ELY Mercury
Regulation
21 CFR 872.3070
Device class
Class II
Review panel
Dental
Applicant
Aleaciones Dentales Zeyco, S.A. DE C.V. Calz. Lazaro Cardenas #2838, Guadalajara, MX
510(k) summary
Statement
Third party review
No

Clearances, product code ELY

Trailing 12 months

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

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