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Dental

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

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RecordFirmDate
ESG-1 ELECTROSONOGRAM (ESG-1) (K970116)Myo-Tronics, Inc.1997-04-02
ULTRA-BLEND PLUS (K970113)Ultradent Products, Inc.1997-04-02
PROSTYLE INTRA (K970975)Planmeca Oy1997-04-01
STERI-OSS TIODIZED SCREW (K964739)Steri-Oss, Inc.1997-03-31
ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT (K963843)Micro Motors, Inc.1997-03-31
PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE (K962370)Challenge Products, Inc.1997-03-31
KALGINATE IMPRESSION MATERIAL (K970594)Teledyne Water Pik1997-03-31
TEETHMATE F-1 (K965091)Kuraray Company, Ltd.1997-03-27
AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL (K970433)Dentsply Intl.1997-03-27
JELENKO NO.1 (CODE NAME RD-0601) (K970068)J.F. Jelenko & Co., Inc.1997-03-24
THERMAPREP PLUS OVEN (K970134)Tulsa Dental Products, Ltd.1997-03-21
KREATIV KURING LIGHT SYSTEM (K962376)Kreativ, Inc.1997-03-21
CUTTERSIL COMFORT (K965163)Heraeus Kulzer, Inc.1997-03-19
CUTTERSIL COMFORT HARDENER (K965165)Heraeus Kulzer, Inc.1997-03-19
T1 CONTROL HIGH SPEED DENTAL HANDPIECE (K965238)Siemens AG1997-03-19
ILT ARGON HP (K964524)Ion Laser Technology1997-03-18
SINGLE TOOT ABUTMENT SYSTEM (STA OR ST ABUTMENT ) FOR SINGLE OOTH CEMENT RETAINED RESTORATIONS (K965077)Implant Innovations, Inc.1997-03-17
RADX SYSTEM (K965203)Electro Medical Systems, Inc.1997-03-17
ULTRACAL XS (K970114)Ultradent Products, Inc.1997-03-14
OOLI-U(TONGUE SCRAPER) (K970042)Telefax Intl.1997-03-14
CYTOPLAST GBR (K964342)Osteogenics Co.1997-03-11
SOOTHING WATER-FILLED TEETHER (K965082)Consolidated Stores Corp.1997-03-11
INTRAORAL MANDIBULAR DISTRACTION DEVICE (K970256)Medicon EG1997-03-11
SOLARO 33 (K970045)Metalor Dental USA Corp.1997-03-05
REPLACE TITANIUM IMPLANT SYSTEM (K964220)Steri-Oss, Inc.1997-03-05
STERILE WATER PUMP (K970002)Micro Motors, Inc.1997-03-05
AUROFLUID 22 (K970044)Metalor Dental USA Corp.1997-03-05
DENTSPLY PRECISION TORQUE SYSTEM (K964046)Dentsply Intl.1997-03-04
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER (K964860)Bell Intl., Inc.1997-03-03
IMZ 2000 INTERLOCK 12/3 - SCREW (K963522)Imz, GmbH1997-03-03
IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM (K963495)Imz, GmbH1997-03-03
MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN (K964863)Bell Intl., Inc.1997-02-28
3M QUIKPLUS SYSTEM (K970168)3M Company1997-02-27
ARGI-SATIN OR OPTI0-STAR (K965216)Argen Precious Metals, Inc.1997-02-27
SPETEMP (K964808)Ultradent Products, Inc.1997-02-26
PM 2002 CC PROLINE (K970263)Planmeca Oy1997-02-26
LIFECORE CONICAL ABUTMENT (K965135)Lifecore Biomedical, Inc.1997-02-25
THREADLOC DENTAL IMPLANT SYSTEMS (K964768)Sulzer Calcitek, Inc.1997-02-25
PERFECTIM (K964692)J. Morita USA, Inc.1997-02-25
DENTEMP ONE STEP (K964773)Majestic Drug Co., Inc.1997-02-21
DENTINSENSE B/C (K965138)Centrix, Inc.1997-02-14
STERI-OSS GOLD ATTACHMENT SYSTEM (K963945)Steri-Oss, Inc.1997-02-11
PFINGST PRESSURE PASTE (K965026)Pfingst & Co., Inc.1997-02-10
DERMADAM (K964810)Ultradent Products, Inc.1997-02-10
MINERAL TRIOXIDE AGGREGATE (MTA) (K964174)Tulsa Dental Products, Ltd.1997-02-10
TEMPFIL C&B (K964981)Sybron Dental Specialties, Inc.1997-02-10
TEFGEN GUIDED TISSUE MEMBRANE (K964656)American Custom Medical, Inc.1997-02-10
WHITE CORE (K964931)Bisco, Inc.1997-02-10
SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM (K962576)Calcitek, Inc.1997-02-10
ROUND DENTAL BUR (K964944)Steri-Oss, Inc.1997-02-10
DENTINSENSE (K964735)Centrix, Inc.1997-02-05
TCB TEMPORARY CROWN AND BRIDGE MATERIAL (K964691)Scican1997-02-04
ULTRA-ETCH STAT (K965060)Ultradent Products, Inc.1997-01-31
PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT (K965072)Kaycor Intl., Ltd.1997-01-27
VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE (K964649)Howmedica Leibinger, Inc.1997-01-24
TAP (K964516)Nellcor Puritan Bennett, Inc.1997-01-24
TONY RISO 25/30 MULTIFUNCTION SCALER (K964320)Tony Riso Co., Inc.1997-01-23
CALCIUM HYDROXIDE MEDICAMENT (K964191)Sybron Dental Specialties, Inc.1997-01-22
TETRIC CERAM (K964285)Ivoclar North America, Inc.1997-01-22
DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) (K964619)Sds Dental, Inc.1997-01-22
DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED (K963548)Mrlb Intl., Inc.1997-01-22
SAFETY INJECTION SYSTEM (K962999)Integritech, Inc.1997-01-22
PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR (K964525)Dentsply Intl.1997-01-22
SIRIUS 10, 10L, 40, 40L (K961275)Micro-Mega Societe Anonyme1997-01-17
AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) (K964772)Ivoclar North America, Inc.1997-01-17
BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE) (K964330)BioHorizons Implant Systems, Inc.1997-01-17
PULPDENT SNOOP (K964430)Pulpdent Corp.1997-01-17
AURORA 53 (K964949)Gateway Alloys, Inc.1997-01-13
EL DORADO 40 (K964941)Gateway Alloys, Inc.1997-01-13
AURORA 52 (PM-01) (K964948)Gateway Alloys, Inc.1997-01-13
LA PLATA 28 (PM-28) (K964950)Gateway Alloys, Inc.1997-01-13
TAOS 28 (K964940)Gateway Alloys, Inc.1997-01-13
AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE (K964133)American Dental Products, Inc.1997-01-09
SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS (K964179)S.S. White Mfg., Ltd.1997-01-09
SIRIUS 180, 180L, 230, 230L (K961235)Micro-Mega Societe Anonyme1997-01-08
ARDENT NON GAMMA-2 70 (K964192)Ardent Production Development1997-01-06
ACURAY DIGITAL X-RAY (K963403)New Image Industries, Inc.1997-01-02
SPETEMP EF (K964809)Ultradent Products, Inc.1997-01-02
AS 123 PROSTHETIC INSTRUMENTATION SYSTEM (K963951)BioHorizons Implant Systems, Inc.1996-12-31
ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1 (K964145)Crystal Mark, Inc.1996-12-31
KROMALGIN IMPRESSION MATERIAL (K964177)North American Orthodontic Laboratories, Inc.1996-12-30
BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY (K963699)Belmont Equipment Corp.1996-12-23
ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM (K964659)Dentsply Intl.1996-12-23
LA PLATA 40 (K964792)Gateway Alloys, Inc.1996-12-20
PACIFIC 56 (CB-40) (K964837)Gateway Alloys, Inc.1996-12-20
LA PLATA 39 (K964789)Gateway Alloys, Inc.1996-12-20
PALLADIA 85 (PM-13) (K964838)Gateway Alloys, Inc.1996-12-20
EL DORADO 55 (K964788)Gateway Alloys, Inc.1996-12-20
MICADENT (K964059)Hampton Research1996-12-19
SOLDER 615 (K964708)Gateway Alloys, Inc.1996-12-16
REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. (K963747)Whitehill Manufacturing, Inc.1996-12-16
SOLDER 585 (K964707)Gateway Alloys, Inc.1996-12-16
SOLDER GPW (K964713)Gateway Alloys, Inc.1996-12-16
SOLDER 650 (K964706)Gateway Alloys, Inc.1996-12-16
CHROMOPRINT CHROMATIC ALGINATE IMPRESSION MATERIAL (K964323)Fen Dental Mfg., Inc.1996-12-16
SOLDER GPY (K964705)Gateway Alloys, Inc.1996-12-16
SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE (K964328)Synthes (Usa)1996-12-13
JEL-40 (CODE NAME RD-0430) (K964158)Jelenko Co.1996-12-13
ULTRADENT UNIVERSAL DENTIN SEALANT (K963979)Ultradent Products, Inc.1996-12-12
IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID (K963746)Whitehill Oral Technologies, Inc.1996-12-12
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