510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K852145Substantially Equivalent

Capa Pre-Formed Porcelain Crown

Capa Industries, Vienna VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852145 is the FDA 510(k) clearance record for CAPA PRE-FORMED PORCELAIN CROWN, a class II device, cleared for Capa Industries on under FDA product code ELL (Teeth, Porcelain). FDA records list one 510(k) clearance for Capa Industries. As of , FDA records show no recalls naming K852145.

Clearance record

Decision date
Received
(47 days to decision)
Product code
ELL Teeth, Porcelain
Regulation
21 CFR 872.3920
Device class
Class II
Review panel
Dental
Applicant
Capa Industries P.O. Box 961, Vienna VA
Third party review
No

Clearances, product code ELL

Trailing 12 months

FDA records hold no clearances under product code ELL in the trailing twelve months.

FDA records show no clearances under product code ELL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260