510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K972485Substantially Equivalent

Cimpat N

Arent, Fox, Kintner, Plotkin & Kahn, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972485 is the FDA 510(k) clearance record for CIMPAT N, a class II device, cleared for Arent, Fox, Kintner, Plotkin & Kahn on under FDA product code EMA (Cement, Dental). FDA records list one 510(k) clearance for Arent, Fox, Kintner, Plotkin & Kahn. As of , FDA records show no recalls naming K972485.

Clearance record

Decision date
Received
(68 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Arent, Fox, Kintner, Plotkin & Kahn 1050 Connecticut Ave., NW, Washington DC
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