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Dental

12,644 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
RESPIRE BLUE SERIES (K111207)Respire Medical2011-08-23
ELECTROTORQUE TLC (K103027)Kaltenbach & Voigt GmbH2011-08-19
E-CUBE (K111616)Saeshin Precision Co., Ltd.2011-08-19
CAVIOS CAVITY LINER (K111668)Neodental Chemical Products Co., Ltd.2011-08-19
ACE TRIMARK TRICAM DENTAL IMPLANT (K103790)Ace Surgical Supply Company, Inc.2011-08-18
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC (K103699)Exactech, Inc.2011-08-12
ZIRPRIME (K111383)Noritake Co., Inc.2011-08-12
NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS (K110580)Straumann USA2011-08-12
ORIGIN ZIRCONIA (K110719)B&D Dental Technologies2011-08-11
ANODIZED HEALING COLLAR (K111852)Zimmer Dental, Inc.2011-08-11
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS (K111199)Intra-Lock International, Inc.2011-08-08
B1P ADHESIVE (K111431)Pentron Clinical2011-08-01
OSI O-BALL ABUTMENT HEAD IMPLANTS (K110548)Juell Dental2011-07-29
BIODENTA CUSTOMIZED ABUTMENT (K110778)Biodenta Swiss AG2011-07-29
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN (K110600)Collagen Matrix, Inc.2011-07-29
ACRYLIC HERBST APPLIANCE (K111009)Embassy Dental Laboratory2011-07-22
ROTOGRAPH EVO 3D (K111152)Villa Sistemi Medicali S.P.A.2011-07-22
APNEA GUARD (K111110)Advanced Brain Monitoring, Inc.2011-07-22
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE (K101453)Obi Biologics, Inc.2011-07-21
AIDITE ZIRCONIA DENTAL CERAMICS (K111291)Qinhuangdao Aidite High-Technical Ceramics Co, Ltd.2011-07-20
OSSEOFUSE DENTAL IMPLANT SYSTEM (K110577)Dynamic Innovations, Inc.2011-07-14
PANOURA 18S (K111231)The Yoshida Dental Mfg. Co., Ltd.2011-07-13
ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN (K111179)Siesta Medical, Inc.2011-07-01
SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE (K111107)Noritake Co., Inc.2011-06-30
PROVU (TM) DENTAL X-RAY SYSTEM (K102573)Advanced Image Science, Inc.2011-06-30
GC AADVA BO AC ABUTMENTS (K103234)GC America, Inc.2011-06-30
15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE (K111581)Nobel Biocare AB2011-06-23
METAL OPAQUER (K110859)Apex Dental Materials, Inc.2011-06-23
ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT (K101005)Astra Tech AB2011-06-21
FIT CHECKER ADVANCED (K110871)GC America, Inc.2011-06-17
FIXTEMP C&B (K102917)Exacta Dental Direct, Inc.2011-06-17
NOBELPROCERA ZI ABUTMENT THOMMEN PLATFORMS (K110171)Nobel Biocare USA, LLC2011-06-15
TEMPFLEX (K110747)Kerr Corporation2011-06-14
AEU-26L ELCTRONIC ENDODONTIC SYSTEM (K111078)Aseptico, Inc.2011-06-14
ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT (K110640)Astra Tech, Inc.2011-06-10
TEMPOCEM (K110759)Dmg USA, Inc.2011-06-10
ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT (K110356)Astra Tech, Inc.2011-06-10
KJ MASK (K103019)Kj Meditech Co., Ltd.2011-06-09
MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM (K110753)Dentsply International, Inc.2011-06-06
CLEARTEMP (K111017)Ultradent Products, Inc.2011-06-06
ORTHO EASY PIN (K110275)Forestadent Bernhard Forster GmbH2011-06-03
SUGLUE-10 (K110508)3M Espe AG2011-06-03
CIMARA (K110589)Voco GmbH2011-05-27
AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY (K111330)Skanray Technologies2011-05-27
SILJETR SYSTEM (K110642)Danville Materials, Inc.2011-05-27
E3 TORQUE CONTROL MOTOR (K103653)Dentsply International, Inc.2011-05-26
GOOD NIGHT (K102463)Larry V Connell, Dmd2011-05-25
PRO-V COAT (K103514)Bisco, Inc.2011-05-25
ADHESIVE EXL-759 (K110302)3M Espe AG2011-05-19
CERAMIC BRACKETS (K110335)Ortho Organizers, Inc.2011-05-19
SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL (K110484)Novocol, Inc.2011-05-17
REMOTE VIEW SOFTWARE (K111321)Cariescan , Ltd.2011-05-17
HEISENBERG DYEING LIQUIDS (K111257)3M Espe AG2011-05-13
BEAUTIBOND MULTI (K110235)Shofu Dental Corp.2011-05-13
CLICK-IT (K111234)Tp Orthodontics, Inc.2011-05-13
BEAUTIBOND MULTI PR PLUS (K110252)Shofu Dental Corp.2011-05-13
ENDOBON XENOGRAFT GRANULES (K110449)Biomet 3i2011-05-13
AURADORM (NEUROMUSCULAR SLEEP) (K101155)Sleepwright2011-05-12
NANOGEN (K102208)Orthogen, LLC2011-05-06
RELYX LUTING PLUS AUTOMIX (K111185)3M Espe Dental Products2011-05-05
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS (K102307)Genoss Co., Ltd.2011-05-04
QUICK UP (K110440)Voco GmbH2011-05-04
PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID (K110037)Heraeus Kulzer, LLC2011-04-29
VALO CORDLESS (K110582)Ultradent Products, Inc.2011-04-28
TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS (K102517)Thunder Tiger Corp.2011-04-27
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM (K103194)Intra-Lock International, Inc.2011-04-21
COMPUTED DENTAL RADIOGRAPHY (K110768)Schick Technologies, Inc.2011-04-20
OSTEOSCAF (K101827)Texas Innovative Medical Devices (Dba) Skeletal2011-04-20
SPI TITANIUM BASE FOR CAD/CAM (K102804)Thommen Medical AG2011-04-20
BLUE SKY BIO DENTAL IMPLANT SYSTEM (K102034)Blue Sky Bio, LLC2011-04-19
STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064, (K101201)Kat Implants, LLC2011-04-13
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) (K103556)Ivoclar Vivadent, Inc.2011-04-13
ARCHITEX SPACE MAINTENANCE SYSTEM (K110259)Medtronic Sofamor Danek USA, Inc.2011-04-13
AMC-20 PORTABLE DENTAL CART MODEL AMC-20 (K101332)Aseptico, Inc.2011-04-11
TAKE 1 ADVANCED RIGID TRAY (K110092)Kerr Corporation2011-04-08
PORTABLE X-RAY SYSTEM (K103600)Digimed Corporation2011-04-08
PRELUDE III TONGUE SUSPENSION SYSTEM (K110127)Siesta Medical, Inc.2011-04-08
ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT (K103759)Astra Tech, Inc.2011-04-08
UTA AND UHA (K102467)Uta2011-04-07
EMS AIR-FLOW MASTER PIEZON (K110173)E.M.S Electro Medical Systems S.A2011-04-07
IMPRESSION COMPOUND (K110378)Spofadental2011-04-05
ESTELITE COLOR (K110178)Tokuyama Dental Corporation2011-04-05
OSSEOTITE II MODEL XIFOSSXXX (K100724)Biomet 3i, Inc.2011-04-01
SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE (K110796)Biomers Products, LLC2011-03-31
BPA-FREE PIT AND FISSURE SEALANT (K110058)Novocol Inc. Dba Septodont and Confi-Dental Produc2011-03-31
TDS ABUTMENT FOR FRIADENT XIVE (K103339)Pou YU Biotechnology Co., Ltd.2011-03-31
LAKONG ULTRASONIC SCALER (K103498)Lakong Medical Device Company, Ltd.2011-03-31
IOS FASTSCAN SPRAY (K103586)Ios Technnologies, Inc.2011-03-30
PANTINO PRO POSITINER (K102521)Somnomed, Inc.2011-03-28
FIT TEST C&B (K110050)Voco GmbH2011-03-28
NEW STETIC ACRYLICS (K102874)New Stetic2011-03-28
ORTHODONTIC SCREW (K103105)Osstem Implant Co., Ltd.2011-03-25
VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS (K102640)Vertex-Dental B.V.2011-03-25
ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT (K102241)Anthogyr Sas2011-03-23
APOLONIA LASER IMPLANT SYSTEM (K102635)Csm Implant Co., Ltd.2011-03-22
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE (K103136)Materialise NV2011-03-18
INTRA SKAN DC (K103579)Skanray Technologies2011-03-18
ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAY (K110371)Panoramic Corp.2011-03-17
PLANMECA PROMAX 3D MID (K103689)Planmeca Oy2011-03-17
ZENOFLEX DIMENSION (K103773)Wieland Dental + Technik GmbH & Co. KG2011-03-16
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