510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213609Substantially Equivalent

NOVA RESIN dual cure, self adhesive resin cement

Imicryl Dis Malzemeleri Sanayi ve Ticaret A.S., Konya, TR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213609 is the FDA 510(k) clearance record for NOVA RESIN dual cure, self adhesive resin cement, a class II device, cleared for Imicryl Dis Malzemeleri Sanayi VE Ticaret AS on under FDA product code EMA (Cement, Dental). FDA records list 5 510(k) clearances for Imicryl Dis Malzemeleri Sanayi VE Ticaret AS, from to . As of , FDA records show no recalls naming K213609.

Clearance record

Decision date
Received
(267 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS Fetih Mahallesi Mahir Sokak No:5/201 Karatay, Konya, TR
510(k) summary
Summary PDF
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