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Dental

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

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RecordFirmDate
AUROFLUID CPF (K982606)Metalor Dental USA Corp.1998-10-15
STERNOMEGA COMPOMER CEMENT (K982895)Sterngold/Implamed1998-10-09
TEMPBOND CLEAR-2 (K982590)Sybron Dental Specialties, Inc.1998-10-08
ULTRACAM (K973410)W. Edward Johansen1998-10-08
MILLENNIUM (K980585)Biolase Technology, Inc.1998-10-08
DELTON FS DIRECT DELIVERY SYSTEM (K982564)Dentsply Intl.1998-10-06
LINER 1:HARD RELINE LIQUID (K981861)Harry J. Bosworth Co.1998-10-01
KURER CROWN SAVER K4 ANCHOR SYSTEM-THE UNIVERSAL KIT, KURER STANDARD K4 ANCHOR SYSTEM- THE READY CORE KIT, KURER FIN-LOC (K983161)Sabre-K , Ltd.1998-09-30
TEMPFIL F - 2 (K982459)Sybron Dental Specialties, Inc.1998-09-30
MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1 (K982779)Medental Intl.1998-09-30
ORTHO IMPLANT AND ACCESSORIES (K982509)Straumann USA1998-09-30
AIR TECHNIQUES' AIRDENT II (K981564)Air Techniques, Inc.1998-09-24
STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT (K982400)Steri-Oss, Inc.1998-09-23
CHROMA ZONE COLOR STAIN (K982259)Kuraray America, Inc.1998-09-22
SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT (K982305)Sulzer Calcitek, Inc.1998-09-22
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM (K982394)Dentsply Intl.1998-09-21
BIO-OSS COLLAGEN (K974399)Geistlich-Pharma1998-09-16
ORAL POTENTIAL METER (OPM) (K982105)Pertec of Wisconsin, Inc.1998-09-16
CLEAN SOURCE I, MODEL CS1000 (K981144)Aquarius Technologies, Inc.1998-09-15
VARIOUS DENTAL IMPLANTS (K982111)Biotech Medical Instruments Corp.1998-09-15
BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM (K982139)Bionx Implants, Inc.1998-09-15
BIO-OSS ANORGANIC BOVINE BONE (K970321)Geistlich-Pharma1998-09-15
PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH. (K982480)Dentalview, Inc.1998-09-15
RENEW (K982729)Bisco, Inc.1998-09-15
SPECTRUM 800 CURING UNIT (K982318)Dentsply Intl.1998-09-15
CHEMICAL CURE COMPOSITE WITH ENAMEL BOND (K982191)Medental Intl.1998-09-14
JUMBO SILVER-REINFORCED GLASS IONOMER (K982665)Centrix, Inc.1998-09-08
ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT (K982865)Atrix Laboratories, Inc.1998-09-08
ALIGN SYSTEM (K981095)Align Technology1998-09-08
QUICK TAP SELF DRILLING SCREW (K982927)Kinamed, Inc.1998-09-08
IPS EMPRESS 2 (K982616)Ivoclar North America, Inc.1998-09-08
FRIALIT-2 CORABASE (K980630)Friatec AG1998-09-04
FLUID CONTROL (K982117)T.A. Coleman Ent.1998-09-04
AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM (K982088)Ortho Kinetics Corp.1998-09-04
PYRAMID (K982645)Bisco, Inc.1998-09-02
ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI (K981970)Cavex Holland BV1998-09-02
MODEL MS-2 HANDPIECE (K982050)Parkell, Inc.1998-09-02
VIVACAP HR (K982460)Ab Ardent1998-08-24
THE SNORE PEACE (K981923)The Snore Peace Group1998-08-24
TOKUYAMA SOFRELINER (K982537)Tokuyama America, Inc.1998-08-24
GLASIONOMER CEMENT CX PLUS (K982461)Shofu Dental Corp.1998-08-24
AIRDENT RADIANCE CURING LIGHT (K982615)Air Techniques, Inc.1998-08-24
VIVALLOY HR (K982458)Ab Ardent1998-08-24
WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM (K981937)Welch Allyn, Inc.1998-08-24
AMALCAP PLUS (K982456)Ab Ardent1998-08-24
PLAQ-ATAQ-I (K980995)Ethicare1998-08-20
SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES (K981890)Synthes (Usa)1998-08-18
APOLLO 95E (K981948)Dental/Medical Diagnostic Systems, Inc.1998-08-18
DYTRACT FLOW RESTORATIVE (K982395)Dentsply Intl.1998-08-18
OPC LOWWEAR PORCELAIN (K982377)Jeneric/Pentron, Inc.1998-08-18
3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT (K980083)Implant Innovations, Inc.1998-08-17
BI-DENT (K982229)Valley Forge Scientific Corp.1998-08-13
BW-1 (CODE NAME RD-0807) (K981244)J.F. Jelenko & Co., Inc.1998-08-13
JELFINE-52 (CODE NAME RD-0901) (K981257)J.F. Jelenko & Co., Inc.1998-08-13
BREATHAID TONGUE SCRAPER (K981808)Breathaid, LLC1998-08-11
BONETRAP (K980049)Bladhs Plast AB1998-08-11
PRO-FLEX DISPOSABLE PROPHY ANGLE (K981869)Professional Dental Mfg., Inc.1998-08-11
DIGITAL DOC (K981663)Digital Doc, LLC1998-08-10
ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) (K982201)Foremost Dental Mfg., Inc.1998-08-10
ESTENIA (K982164)Kuraray America, Inc.1998-08-10
3M DENT II SYSTEM (K981647)3M Company1998-08-09
ANTAGON PORCELAIN (K982129)European Dental Imports, Inc.1998-08-04
THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES (K980106)Proma, Inc.1998-08-03
VITA TITANIUM PORCELAIN (K982664)Vident1998-08-02
PRODIGY 2 (K982148)Sybron Dental Specialties, Inc.1998-07-31
MTA MATERIAL II (K981620)Dentsply Intl.1998-07-31
POLYCARBOXYLATE CEMENT (K980990)Medental Intl.1998-07-31
SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT (K981562)Sulzer Calcitek, Inc.1998-07-30
LIQUID A (K981618)Harry J. Bosworth Co.1998-07-28
MCS-MEDICATED CANAL SEALER (K973636)Dr. Howard Martin, P.A.1998-07-27
RESOR-PIN RESORBABLE MEMBRANE PIN (K972817)Geistlich-Pharma1998-07-24
VIPERCAM (K981534)Integra Medical1998-07-23
VERABOND 2 (K982094)Aalba Dent, Inc.1998-07-22
TRUBYTE DENTURE BOND DENTURE BONDING AGENT (K982007)Dentsply Intl.1998-07-22
DIAMOND PROBE/PERIO 2000 SYSTEM (DEN980003)Diamond General Development Corp.1998-07-17
MEMBRANE TACK (K981459)Biomet, Inc.1998-07-14
PERMACEM AUTOMIX LUTING CEMENT SYSTEM (K981813)Foremost Dental Mfg., Inc.1998-07-10
PRILANE (K981524)Gresco Products, Inc.1998-07-10
FLOWABLE COMPOSITE (K981965)Dentsply Intl.1998-07-10
PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM (K974655)Prep Technology Corp.1998-07-09
ARISTON PHC LINER (K981335)Ivoclar North America, Inc.1998-07-02
ARISTON PHC (K981264)Ivoclar USA, Inc.1998-07-02
OSTEOGRAF/N-300 (K981182)Ceramed Dental, LLC1998-07-02
SILCAST (CODE NAME RD-0118) (K981247)J.F. Jelenko & Co., Inc.1998-07-01
SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR (K981362)Synthes (Usa)1998-06-29
OSTEOGRAF/N-700 (K981214)Ceramed Dental, LLC1998-06-26
ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE (K982009)Scitech Solutions, Inc.1998-06-25
GC FUJI ORTHO LC (K981461)GC America, Inc.1998-06-25
ORTHODONTIC BRACES (K981433)Midwest Orthodontic Mfg.1998-06-25
SYNTHES (USA) RATCHETING DISTRACTOR (K981275)Synthes (Usa)1998-06-25
SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET (K981075)Synthes (Usa)1998-06-22
MRS-400, MAXI 400, MRSL-400, MAXI 400L (K981990)D.B.I. America Corp.1998-06-22
GC FUJI BOND LC (K981514)GC America, Inc.1998-06-16
ALLOYBOND (K981383)Southern Dental Industries, Inc.1998-06-16
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH (K974761)John O. Butler Co.1998-06-16
KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 (K980216)Kreativ, Inc.1998-06-16
KERR HARD DENTURE RELINE MATERIAL (K981448)Sybron Dental Specialties, Inc.1998-06-16
WATER FILLED GUM SOOTHER (K981202)Corium Corp.1998-06-16
3M M.G. MATERIAL (K981325)3M Company1998-06-11
ODONTOSURGE 2 (K981390)Periogiene1998-06-11
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