510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K901256Substantially Equivalent

Amalcap Plus

Ivoclar North America, Inc., Amherst NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901256 is the FDA 510(k) clearance record for AMALCAP PLUS, a class II device, cleared for Ivoclar North America, Inc. on under FDA product code EJJ (Alloy, Amalgam). FDA records list 131 510(k) clearances for Ivoclar North America, Inc., from to . As of , FDA records show no recalls naming K901256.

Clearance record

Decision date
Received
(43 days to decision)
Product code
EJJ Alloy, Amalgam
Regulation
21 CFR 872.3070
Device class
Class II
Review panel
Dental
Applicant
Ivoclar North America, Inc. 175 Pineview Dr., Amherst NY
Third party review
No

Clearances, product code EJJ

Trailing 12 months

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

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