Medical Device Manufacturer · US , Mchenry , IL

Shofu Dental Corp. - FDA 510(k) Cleared Devices

59 submissions · 59 cleared · Since 1981
59
Total
59
Cleared
0
Denied
59 devices
26-50 of 59
Cleared Jun 30, 1997
HI DENSE TC
K971927 · EMA
Dental · 34d
Cleared Oct 04, 1995
IMPERVA FLUOROBOND
K953612 · KLE
Dental · 63d
Cleared Oct 04, 1995
IMPERVA ENSURABOND
K953613 · KLE
Dental · 63d
Cleared Feb 27, 1995
HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE
K945451 · EMA
Dental · 112d
Cleared May 02, 1994
HY BOND, GLASIONOMER CX
K940122 · EMA
Dental · 112d
Cleared Sep 01, 1992
LITE FIL II A
K920892 · EBF
Dental · 188d
Cleared Sep 01, 1992
LITE FILL II P
K920893 · EBF
Dental · 188d
Cleared Dec 03, 1991
IMPERVA DUAL
K913946 · KLE
Dental · 90d
Cleared Oct 09, 1991
IMPERVA BOND
K913947 · EBF
Dental · 35d
Cleared Aug 14, 1990
ULTRA II PORCELAIN POLISHING PASTE
K896071 · EJR
Dental · 299d
Cleared Jul 14, 1989
CRYSTAR(TM) ANTI-GREENING LIQUID
K893481 · ELL
Dental · 71d
Cleared Dec 08, 1988
CRYSTAR(TM) VINTAGE PORCELAIN
K884214 · ELL
Dental · 63d
Cleared Jul 21, 1987
IMPERVA-P
K871898 · EBF
Dental · 67d
Cleared Jul 21, 1987
IMPERVA-A
K871899 · EBF
Dental · 67d
Cleared Aug 26, 1986
KULZER GLASS IONOMER LINER
K863141 · EMA
Dental · 11d
Cleared Jun 23, 1986
SHOFU LINING CEMENT
K862280 · EMA
Dental · 7d
Cleared Apr 25, 1986
GLASIONOMER BASE CEMENT
K861005 · EMA
Dental · 38d
Cleared Dec 27, 1985
HYBRID POINTS
K854347 · DZP
Dental · 59d
Cleared Apr 10, 1985
GLAS IONOMER CEMENT
K850913 · EMA
Dental · 36d
Cleared Dec 03, 1984
ISOSTATIC CONDENSER
K843901 · EKG
Dental · 61d
Cleared May 14, 1984
GLAS IONOMER CEMENT
K841195 · EMA
Dental · 54d
Cleared May 11, 1984
HY-BOND ZINC OXIDE EUGENOL TEMP.
K841196 · EMA
Dental · 51d
Cleared Apr 25, 1984
CRYSTAR PORCELAIN MARGIN POWDER/LIQUID
K840873 · EIH
Dental · 58d
Cleared Mar 06, 1984
SHOFU PORCELAIN STAIN
K834497 · EIH
Dental · 77d
Cleared Dec 29, 1983
CRYSTAR PORCELAIN
K833643 · EIH
Dental · 73d
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