510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901909Substantially Equivalent

Silamat (Amalgamator)

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

K901909 is the FDA 510(k) clearance record for SILAMAT (AMALGAMATOR), a class I device, cleared for Ivoclar North America, Inc. on under FDA product code EFD (Amalgamator, Dental, Ac-Powered). FDA records list 131 510(k) clearances for Ivoclar North America, Inc., from to . As of , FDA records show no recalls naming K901909.

Clearance record

Decision date
Received
(56 days to decision)
Product code
EFD Amalgamator, Dental, Ac-Powered
Regulation
21 CFR 872.3100
Device class
Class I
Review panel
Dental
Applicant
Ivoclar North America, Inc. 175 Pineview Dr., Amherst NY
Third party review
No

Clearances, product code EFD

Trailing 12 months

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

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