510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791160Substantially Equivalent

Dentaleen

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

K791160 is the FDA 510(k) clearance record for DENTALEEN, a class II device, cleared for Denpac Corp. on under FDA product code EMA (Cement, Dental). FDA records list 4 510(k) clearances for Denpac Corp., from to . As of , FDA records show no recalls naming K791160.

Clearance record

Decision date
Received
(244 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Denpac Corp. 803 N. Front St. Suite 3, Mchenry IL
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