EFD · Class I · 21 CFR 872.3100

FDA Product Code EFD: Amalgamator, Dental, Ac-powered

Leading manufacturers include Degussa AG, Ivoclar North America, Inc. and L.D. Caulk Co..

15

Total

15

Cleared

50d

Avg days

1977

Since

FDA 510(k) Cleared Amalgamator, Dental, Ac-powered Devices (Product Code EFD)

15 devices

1–15 of 15

Cleared Jul 26, 1999

Cleared Oct 06, 1992

Ivoclar North America, Inc.

Cleared Mar 02, 1992

AUTOMIX DENTAL AMALGAMATOR

Kerr Corporation (Danbury)

Cleared Nov 13, 1991

DUOMAT 3 AMALGAMATOR

Cleared Nov 13, 1991

MIXOMAT AMALGAMATOR

Cleared Nov 07, 1991

DENTOMAT 3 AMALGAMATORS

Cleared Jun 22, 1990

SILAMAT (AMALGAMATOR)

Ivoclar North America, Inc.

Cleared Jun 12, 1989

DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.

Implant Innovations International, Inc.

Cleared May 30, 1989

Cleared Apr 21, 1978

DENTAL AMALGAMATOR

About Product Code EFD - Regulatory Context

Related FDA 510(k) Regulatory Insights