Medical Device Manufacturer · US , Walker , MI

Dentsply Intl. - FDA 510(k) Cleared Devices

279 submissions · 279 cleared · Since 1976
279
Total
279
Cleared
0
Denied
279 devices
101-125 of 279
Cleared Mar 23, 1995
DYRACT II RESTORATIVE
K950991 · EBF
Dental · 20d
Cleared Dec 29, 1994
TOTAL ETCH GEL
K945769 · EBF
Dental · 57d
Cleared Sep 21, 1994
PRESTERILIZED ENDODONTIC FILES
K943584 · EKJ
Dental · 61d
Cleared Aug 29, 1994
NEW LUTING CEMENT MATERIAL (NLC)
K940914 · EMA
Dental · 185d
Cleared Aug 29, 1994
SOFTWEAR PORCELAIN SYSTEM
K943582 · EIH
Dental · 38d
Cleared Aug 23, 1994
CAPTURE IMPRESSION MATERIAL
K943574 · ELW
Dental · 32d
Cleared Jun 10, 1994
FLUORIDE-PSA PRIME/ADHESIVE
K941572 · KLE
Dental · 71d
Cleared Jun 10, 1994
CAULK TOOTH CONDITIONER GEL AND SYRINGE
K942031 · EBF
Dental · 45d
Cleared May 23, 1994
JET UNIT (CJ HANDPIECE)
K941392 · ELC
Dental · 62d
Cleared Apr 29, 1994
MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF)
K940459 · EMA
Dental · 87d
Cleared Apr 28, 1994
PRETREATMENT SOLUTION
K940685 · ELW
Dental · 77d
Cleared Mar 01, 1994
FINESSE PORCELAIN SYSTEM
K940252 · EIH
Dental · 39d
Cleared Aug 25, 1993
VLC DR MATERIAL
K932395 · EBF
Dental · 99d
Cleared Jul 22, 1993
THE MODEL 3003 SCALER
K930698 · ELC
Dental · 162d
Cleared Jul 08, 1993
VARIGLASS VLC GLASS IONOMER
K931229 · EMA
Dental · 120d
Cleared Jul 08, 1993
NEW DENTINE ADHESIVE
K931812 · KLE
Dental · 87d
Cleared May 27, 1993
NEW DENTIN PRIMER
K930504 · KLE
Dental · 115d
Cleared Apr 12, 1993
MULTIPURPOSE RESIN CEMENT
K923473 · EMA
Dental · 272d
Cleared Mar 31, 1993
DUAL CURE RELINE MATERIAL
K926406 · EBI
Dental · 100d
Cleared Dec 23, 1992
NEW TOOTH MATERIAL
K920684 · ELM
Dental · 313d
Cleared Nov 17, 1992
LC TRAY MATERIAL
K923979 · EBH
Dental · 103d
Cleared Oct 26, 1992
DIAMOND COATED DENTAL INSERTS
K923639 · ELC
Dental · 97d
Cleared Sep 29, 1992
BURNOUT MATERIAL
K923586 · EGD
Dental · 71d
Cleared Sep 11, 1992
TRIAD INLAY COMPOSITE
K923236 · EBF
Dental · 72d
Cleared Sep 09, 1992
VENEER CEMENT
K923328 · EMA
Dental · 64d

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