510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802819Substantially Equivalent

Ketac-Cem in Ref. to K802048

Espe Dental Products, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802819 is the FDA 510(k) clearance record for KETAC-CEM IN REF. TO K802048, a class II device, cleared for Espe Dental Products on under FDA product code EMA (Cement, Dental). FDA records list 8 510(k) clearances for Espe Dental Products, from to . As of , FDA records show no recalls naming K802819.

Clearance record

Decision date
Received
(17 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Espe Dental Products 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