510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964773Substantially Equivalent

Dentemp One Step

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

K964773 is the FDA 510(k) clearance record for DENTEMP ONE STEP, a class II device, cleared for Majestic Drug Co., Inc. on under FDA product code EMA (Cement, Dental). FDA records list 3 510(k) clearances for Majestic Drug Co., Inc., from to . As of , FDA records show 2 recalls naming K964773.

Clearance record

Decision date
Received
(86 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Majestic Drug Co., Inc. 711-717 E. 134th St., Bronx NY
510(k) summary
Statement
Third party review
No

Clearances, product code EMA

Trailing 12 months
10 clearances under product code EMA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EMA, trailing twelve months
MonthClearances
November 20250
December 20253
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20261
August 20262
September 20261
October 20260