ClearanceBrief
Panels › Dental › Product code EMA · Class 2

Cement, Dental

Regulation 872.3275

10510(k)s in 12 months (509 all time)
0recalls in 12 months (16 all time)
13recalls that name a 510(k)
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Top companies in EMA

Company510(k)sRecalls
GC America, Inc.300
Voco GmbH262
Shofu Dental Corp.240
Dentsply Intl.190
Pulpdent Corp.140
Sybron Dental Specialties140
3M Company120
Bisco, Inc.92
Espe GmbH (Us)100
Coltene/Whaledent AG90
Decided510(k)Device and applicantCode
Feb 4, 1999K984505MIRACLE MIX POWDER/LIQUID
GC America, Inc.
EMA
Jan 8, 1999K984340STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281
Sterngold/Implamed
EMA
Jan 8, 1999K984248PROCEM
Espe Dental AG, DE
EMA
Dec 10, 1998K983752ALUMINA-ZINC OXIDE POWDERS F AND R
Harry J. Bosworth Co.
EMA
Nov 13, 1998K983361PANAVIA F
Kuraray America, Inc.
EMA
Nov 3, 1998K982773QUICKSET LIQUID AND POWDER
Specialites Septodont
EMA
Oct 22, 1998K983018ZINC PHOSPHATE CEMENT
Medental Intl.
EMA
Oct 19, 1998K982913ZINFOS ZINC PHOSPHATE CEMENT
Scientific Pharmaceuticals, Inc.
EMA
Oct 9, 1998K982895STERNOMEGA COMPOMER CEMENT
Sterngold/Implamed
EMA
Oct 8, 1998K982590TEMPBOND CLEAR-2
Sybron Dental Specialties, Inc.
EMA
Sep 30, 1998K982779MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1
Medental Intl.
EMA
Sep 23, 1998K982400STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT
Steri-Oss, Inc.
EMA
Sep 8, 1998K982665JUMBO SILVER-REINFORCED GLASS IONOMER
Centrix, Inc.
EMA
Aug 24, 1998K982461GLASIONOMER CEMENT CX PLUS
Shofu Dental Corp.
EMA
Jul 31, 1998K980990POLYCARBOXYLATE CEMENT
Medental Intl.
EMA
Jul 28, 1998K981618LIQUID A
Harry J. Bosworth Co.
EMA
Jul 27, 1998K973636MCS-MEDICATED CANAL SEALER
Dr. Howard Martin, P.A.
EMA
Jul 10, 1998K981965FLOWABLE COMPOSITE
Dentsply Intl.
EMA
Jul 2, 1998K981335ARISTON PHC LINER
Ivoclar North America, Inc.
EMA
Jun 5, 1998K973201PROVI CEMENT
S & C Polymer GmbH, DE
EMA
Jun 1, 1998K981370MIRACLE MIX CAPSULE
GC America, Inc.
EMA
Apr 30, 1998K980922PROTEC CEM.
Ivoclar North America, Inc.
EMA
Apr 30, 1998K980568JUMBO GLASS IONOMER CEMENT
Centrix, Inc.
EMA
Apr 13, 1998K980695FUJI I
GC America, Inc.
EMA
Apr 9, 1998K980159OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01
Closure Medical Corp.
EMA
Apr 9, 1998K974097PERIACRYL
Blacklock Medical Products, Inc., CA
EMA
Apr 3, 1998K980682FUJI II
GC America, Inc.
EMA
Feb 24, 1998K980232CLEARFIL DC CEMENT
Kuraray Company, Ltd.
EMA
Feb 2, 1998K974458COMPOLUTE APLICAP
Espe Dental-Medizin GmbH & Co.Kg., DE
EMA
Jan 29, 1998K972935SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL
S.S. White Mfg., Ltd., GB
EMA
Jan 5, 1998K974140ADHESIVE HYBRID IONOMER CEMENT
Dentsply Intl.
EMA
Dec 17, 1997K974014PULPDENT DENTASTIC UNO
Pulpdent Corp.
EMA
Dec 17, 1997K9739613M DENT SYSTEM II PLUS
3M Company
EMA
Dec 2, 1997K973370AQUAPLAST PALATAL STENT
Wfr/Aquaplast Corp.
EMA
Nov 21, 1997K973397SYNTAC SPRINT
Ivoclar North America, Inc.
EMA
Nov 17, 1997K973262KETAC-FIL APLICAP PLUS
Espe GmbH & Co. Kg., DE
EMA
Nov 7, 1997K972965STERI-OSS UNTIL IMPLANT CEMENT
Steri-Oss, Inc.
EMA
Oct 3, 1997K972844TEMP BOND CLEAR
Kerr Dental Materials Center
EMA
Oct 2, 1997K972445PULPDENT OX-OUT
Pulpdent Corp.
EMA
Sep 8, 1997K972485CIMPAT N
Arent, Fox, Kintner, Plotkin & Kahn
EMA
Jul 24, 1997K971642DENTALIS KEZ ENDODONITC SEALER
Neodental Chemical Products Co., Ltd.
EMA
Jun 30, 1997K971927HI DENSE TC
Shofu Dental Corp.
EMA
Jun 3, 1997K970775TEMPO CEM (MULTIPLE)
Foremost Dental Mfg., Inc.
EMA
Jun 3, 1997K970774TEMPOCEM NE (MULTIPLE)
Foremost Dental Mfg., Inc.
EMA
Feb 26, 1997K964808SPETEMP
Ultradent Products, Inc.
EMA
Feb 21, 1997K964773DENTEMP ONE STEP
Majestic Drug Co., Inc.
EMA
Jan 2, 1997K964809SPETEMP EF
Ultradent Products, Inc.
EMA
Nov 15, 1996K963737HYCEM APLICAP
Espe GmbH & Co. Kg., DE
EMA
Oct 11, 1996K962733CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)
Union Broach, Div. Moyco Industries, Inc.
EMA
Sep 30, 1996K962747PULPDENT ENDODONTIC POST CEMENT KIT
Pulpdent Corp.
EMA

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