EFH · Class I · 21 CFR 872.6140

FDA Product Code EFH: Paper, Articulation

Leading manufacturers include Pascal Co., Inc., Ardent Intl., Inc. and Myo-Tronics Research, Inc..

10
Total
10
Cleared
85d
Avg days
1977
Since

FDA 510(k) Cleared Paper, Articulation Devices (Product Code EFH)

10 devices
1–10 of 10
Cleared Feb 10, 1997
PFINGST PRESSURE PASTE
K965026
Pfingst & Co., Inc.
Dental · 55d
Cleared Jan 17, 1992
OCCLUDE
K912632
Pascal Co., Inc.
Dental · 217d
Cleared Jun 06, 1991
HYDENT
K911259
Pascal Co., Inc.
Dental · 76d
Cleared Feb 12, 1987
FIXTECTOR
K864572
Prodent Intl., Inc.
Dental · 84d
Cleared Feb 02, 1987
REVISED T-SCAN SYSTEM
K870032
Sentek, Inc.
Dental · 28d
Cleared Feb 21, 1984
ARTICULATING PAPER
K832647
Ardent Intl., Inc.
Dental · 200d
Cleared Feb 10, 1984
MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY
K833132
Myo-Tronics Research, Inc.
Dental · 150d
Cleared Mar 17, 1981
CENTRIC (BITE) REGISTRATION PASTE
K810498
Wallace A. Erickson & Co.
Dental · 21d
Cleared Jun 20, 1977
ARTICULATING PAPER
K771011
Parker Laboratories, Inc.
Dental · 14d

About Product Code EFH - Regulatory Context