510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984248Substantially Equivalent

Procem

Espe Dental AG, Bavaria D-82228 Seefeld, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984248 is the FDA 510(k) clearance record for PROCEM, a class II device, cleared for Espe Dental AG on under FDA product code EMA (Cement, Dental). FDA records list 29 510(k) clearances for Espe Dental AG, from to . As of , FDA records show no recalls naming K984248.

Clearance record

Decision date
Received
(42 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Espe Dental AG Espe Platz, Bavaria D-82228 Seefeld, DE
510(k) summary
Summary
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