510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K921538Substantially Equivalent

Amalgaphase

Saskan Amalgam Alloys, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921538 is the FDA 510(k) clearance record for AMALGAPHASE, a class II device, cleared for Saskan Amalgam Alloys, Inc. on under FDA product code EJJ (Alloy, Amalgam). FDA records list one 510(k) clearance for Saskan Amalgam Alloys, Inc. As of , FDA records show no recalls naming K921538.

Clearance record

Decision date
Received
(132 days to decision)
Product code
EJJ Alloy, Amalgam
Regulation
21 CFR 872.3070
Device class
Class II
Review panel
Dental
Applicant
Saskan Amalgam Alloys, Inc. 680 N. Lake Shore Dr., Chicago IL
510(k) summary
Statement
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJJ, 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