510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780966Substantially Equivalent

Lee-Alloy Disposable Capsules

Lee Pharmaceuticals, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780966 is the FDA 510(k) clearance record for LEE-ALLOY DISPOSABLE CAPSULES, a class I device, cleared for Lee Pharmaceuticals on under FDA product code DZS (Capsule, Dental, Amalgam). FDA records list 29 510(k) clearances for Lee Pharmaceuticals, from to . As of , FDA records show no recalls naming K780966.

Clearance record

Decision date
Received
(70 days to decision)
Product code
DZS Capsule, Dental, Amalgam
Regulation
21 CFR 872.3110
Device class
Class I
Review panel
Dental
Applicant
Lee Pharmaceuticals 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DZS

Trailing 12 months

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

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