510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003387Substantially Equivalent

Aurofilm Np

Metalor Dental USA Corp., North Attleborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003387 is the FDA 510(k) clearance record for AUROFILM NP, a class II device, cleared for Metalor Dental USA Corp. on under FDA product code EJH (Alloy, Metal, Base). FDA records list 67 510(k) clearances for Metalor Dental USA Corp., from to . As of , FDA records show no recalls naming K003387.

Clearance record

Decision date
Received
(70 days to decision)
Product code
EJH Alloy, Metal, Base
Regulation
21 CFR 872.3710
Device class
Class II
Review panel
Dental
Applicant
Metalor Dental USA Corp. 255 John L. Dietsch Blvd., North Attleborough MA
510(k) summary
Statement
Third party review
No

Clearances, product code EJH

Trailing 12 months

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

FDA records show no clearances under product code EJH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJH, 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