510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821581Substantially Equivalent

Den Temp

Majestic Drug Co., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821581 is the FDA 510(k) clearance record for DEN TEMP, a class I device, cleared for Majestic Drug Co., Inc. on under FDA product code EMB (Zinc Oxide Eugenol). FDA records list 3 510(k) clearances for Majestic Drug Co., Inc., from to . As of , FDA records show no recalls naming K821581.

Clearance record

Decision date
Received
(17 days to decision)
Product code
EMB Zinc Oxide Eugenol
Regulation
21 CFR 872.3275
Device class
Class I
Review panel
Dental
Applicant
Majestic Drug Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EMB

Trailing 12 months

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

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