510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012438Substantially Equivalent

Modification to Panavia 21

Kuraray Medical, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012438 is the FDA 510(k) clearance record for MODIFICATION TO PANAVIA 21, a class II device, cleared for Kuraray Medical, Inc. on under FDA product code EMA (Cement, Dental). FDA records list 42 510(k) clearances for Kuraray Medical, Inc., from to . As of , FDA records show no recalls naming K012438.

Clearance record

Decision date
Received
(36 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Kuraray Medical, Inc. 30th Floor Metlife Bldg., New York NY
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