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

Amalgamator, Dental, Ac-Powered

21 CFR 872.3100 / Dental
FDA source (opens on fda.gov)

EFD is the FDA product code for Amalgamator, Dental, Ac-Powered, a class I device type, regulated under 21 CFR 872.3100. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
EFD
Device name
Amalgamator, Dental, Ac-Powered
Regulation
21 CFR 872.3100
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
1

Clearances, product code EFD

By decision year
15 clearances under product code EFD with a decision year between 1977 and 1999, 1991 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code EFD by decision year
YearClearances
19771
19781
19791
19881
19892
19901
19914
19923
19991

Applicants with the most clearances

Product code EFD
Applicants holding the most 510(k) clearances under product code EFD
ApplicantClearances
Degussa AG3
Ivoclar North America, Inc.2
Acecodent, Inc.1
Espe Dental AG1
Espe Dental Products1
Espe GmbH (US)1
Implant Innovations International, Inc.1
Ipt Technologies, Inc.1
Kerr Corporation (Danbury)1
L.D. Caulk Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order