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

Paper, Articulation

21 CFR 872.6140 / Dental
FDA source (opens on fda.gov)

EFH is the FDA product code for Paper, Articulation, a class I device type, regulated under 21 CFR 872.6140. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EFH
Device name
Paper, Articulation
Regulation
21 CFR 872.6140
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
10
Ingested recalls
0

Clearances, product code EFH

By decision year
10 clearances under product code EFH with a decision year between 1977 and 1997, 1977 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code EFH by decision year
YearClearances
19772
19811
19842
19872
19911
19921
19971

Applicants with the most clearances

Product code EFH
Applicants holding the most 510(k) clearances under product code EFH
ApplicantClearances
Pascal International, Inc.2
Ardent Intl., Inc.1
Dey-Mat, Inc.1
Myo-Tronics Research, Inc.1
Parker Laboratories, Inc.1
Pfingst & Co., Inc.1
Prodent Intl., Inc.1
Sentek, Inc.1
Wallace A. Erickson & Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 69 companies shown, in name order