Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- EAQDetector, Ultraviolet2Product Code
- DYNMouthpiece, Saliva Ejector1Product Code
- EBRUnit, Suction Operatory1Product Code
- EBZActivator, Ultraviolet, For Polymerization2Product Code
- ECCSterilizer, Glass Bead3Product Code
- ECGSterilizer, Boiling Water1Product Code
- EEAPlate, Base, Shellac1Product Code
- EEFClamp, Rubber Dam1Product Code
- EEGHeat Source For Bleaching Teeth1Product Code
- EEJGuard, Disk1Product Code
- EFCWarmer, Anesthetic Tube1Product Code
- EFHPaper, Articulation1Product Code
- EFNCotton, Roll1Product Code
- EFSUnit, Oral Irrigation1Product Code
- EFWToothbrush, Manual1Product Code
- EFXProtector, Silicate1Product Code
- EGDWax, Dental, Intraoral1Product Code
- EHJDisk, Abrasive1Product Code
- EHKCup, Prophylaxis1Product Code
- EHLPoint, Abrasive1Product Code
- EHMStrip, Polishing Agent1Product Code
- EHYTray, Impression, Preformed1Product Code
- EHZEvacuator, Oral Cavity1Product Code
- EIAUnit, Operative Dental1Product Code
- K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus1Cleared 510(K)
- K242404BDC Dental Unit1Cleared 510(K)
- K231297Firstar Dental Unit1Cleared 510(K)
- K233805K51Cleared 510(K)
- K240754N21Cleared 510(K)
- K231845Dental unit Model: Mare1Cleared 510(K)
- K202963ELEC Master, ELEC Master Dual1Cleared 510(K)
- K211556N21Cleared 510(K)
- K213749G7, Dental Operative Unit and Accessories1Cleared 510(K)
- K220873Perceptive electric dental motor and control unit1Cleared 510(K)
- K213742Infinity Pro, Logic, Quality, Sprint1Cleared 510(K)
- K213932A-dec 300, A-dec 5001Cleared 510(K)
- K180935Infinity / Infinity Cross Flex Dental Systems1Cleared 510(K)
- K183347K31Cleared 510(K)
- K183121Qraypen1Cleared 510(K)
- K173608Forest Dental Unit1Cleared 510(K)
- K171872P50 Series Dental Operative Unit and Accessories1Cleared 510(K)
- K152830K31Cleared 510(K)
- K161734Vanguard Dental Unit1Cleared 510(K)
- K161488ESTETICA Dental Treatment Unit and Accessories1Cleared 510(K)
- K152100Evogue Dental Unit1Cleared 510(K)
- K151996TAURUS C11Cleared 510(K)
- K143696Spirit1Cleared 510(K)
- K151045TENEO Dental Treatment Unit and Accessories1Cleared 510(K)
- K150909INTEGO Family and Accesories1Cleared 510(K)
- K150490UnicLine Mobile1Cleared 510(K)
- K142206Dental Unit1Cleared 510(K)
- K141504T-8000 THEROZONE UNIT1Cleared 510(K)
- K133412S200, S3001Cleared 510(K)
- K132245AJAX DENTAL UNIT1Cleared 510(K)
- K132315ERGONOMIC PRODUCTS WORKSTATION1Cleared 510(K)
- K130534DIPLOMAT1Cleared 510(K)
- K130410DENTAL UNIT WITH CHAIR1Cleared 510(K)
- K120239ELEVANCE1Cleared 510(K)
- K110481TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE1Cleared 510(K)
- K111907DYNAMIC DU SERIES PORTABLE DENTAL UNIT1Cleared 510(K)
- K112321CS 12001Cleared 510(K)
- K101332AMC-20 PORTABLE DENTAL CART MODEL AMC-201Cleared 510(K)
- K102223CHALLENGE-EVER1Cleared 510(K)
- K103550YOBOSHI DENTAL UNIT1Cleared 510(K)
- K102234A-DEC 200 DENTAL SYSTEM1Cleared 510(K)
- K100212DENTACENTER/EXPEDITION, MODEL SAF-4301Cleared 510(K)
- K092917STERN'S S250 NORDAM1Cleared 510(K)
- K092851MODEL GDCH-20001Cleared 510(K)
- K091186KODAK 1500 INTRAORAL CAMERA1Cleared 510(K)
- K090079VIVID, MODELS 40-A0001, 40-A0004, 40-A00061Cleared 510(K)
- K082985A-DEC 334/335 DELIVERY SYSTEM1Cleared 510(K)
- K081699PLANMECA SOVEREIGN1Cleared 510(K)
- K081237CRAFTMASTER CONTOUR EQUIPMENT, INC., VISTA MODEL V-20, SATELLITE MOBILE UNIT MODEL ST-98 AND SATELLITE UNIT1Cleared 510(K)
- K082294WESTAR SERIES DENTAL UNITS1Cleared 510(K)
- K080677COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE1Cleared 510(K)
- K080438DENTAL UNIT WITH CHAIR1Cleared 510(K)
- K071485TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 8881Cleared 510(K)
- K063646OPTI1Cleared 510(K)
- K070196FLIGHT DENTAL SYSTEMS A-SERIES DENTAL OPERATIVE UNIT1Cleared 510(K)
- K062897C-U21Cleared 510(K)
- K063302SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES1Cleared 510(K)
- K052574COMPACT PLUS - EXTREME - PERFECT PLUS1Cleared 510(K)
- K061175CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES1Cleared 510(K)
- K050571ABSOLUTE AMERICA1Cleared 510(K)
- K052470F1 SERIES DENTAL CHAIRS WITH OPERATIVE UNIT1Cleared 510(K)
- K051657A-DEC SELF-CONTAINED WATER SYSTEM1Cleared 510(K)
- K050201AEU-14CF EXPENDITION1Cleared 510(K)
- K043496SPACELINE EMCIA, MODEL CU5801Cleared 510(K)
- K043325ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES1Cleared 510(K)
- K042759OPTIMA MX1Cleared 510(K)
- K041805MICROSCOPE SYSTEM1Cleared 510(K)
- K041458MARE DENTAL OPERATIVE UNIT1Cleared 510(K)
- K040529COCOON HYGIENIST1Cleared 510(K)
- K040117UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT1Cleared 510(K)
- K040116HAWK INTRAORAL CAMERA AND ACCESSORIES1Cleared 510(K)
- K033925BIOFREE1Cleared 510(K)
- K040691INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D1Cleared 510(K)
- K033419STV PRO 21Cleared 510(K)
- K032757A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE1Cleared 510(K)
- K032756A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/5331Cleared 510(K)
- K032543SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES1Cleared 510(K)
- K031681STERISIL ANTIMICROBIAL TUBING AND BOTTLE1Cleared 510(K)
- K032904ACUCAM CONCEPT IV FWT, MODEL 110-0185G11Cleared 510(K)
- K032070ELCACAM1Cleared 510(K)
- K032341INTRA ORAL CAMERA SYSTEM AND ACCESSORIES, MODEL CLARIS I3101Cleared 510(K)
- K023896C-18901Cleared 510(K)
- K023815C-1805M1Cleared 510(K)
- K023513LOGOS JUNIOR DENTAL CHAIR AND UNIT1Cleared 510(K)
- K023213RDH-20001Cleared 510(K)
- K022217AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM1Cleared 510(K)
- K021083VERACAM1Cleared 510(K)
- K020833BOYD DELIVERY UNIT1Cleared 510(K)
- K020957ORACAM1Cleared 510(K)
- K020206INTRAORAL CAMERA ME-151Cleared 510(K)
- K013690IDENT-A100 INTRAORAL VIDEO CAMERA1Cleared 510(K)
- K012744INTRAORAL LENS OPTION TO SPECTROSHADE1Cleared 510(K)
- K012505SOPRO595 INTRA ORAL CAMERA1Cleared 510(K)
- K012213GULLIVER AND CLASSE A1Cleared 510(K)
- K011222PORTABELL, MODEL 42001Cleared 510(K)
- K003265CLEANAIR/ CLEANWATER UNIT, MODEL 16001Cleared 510(K)
- K002620SURESMILE SYSTEM1Cleared 510(K)
- K003090MIDMARK PROCENTER INSTRUMENT DELIVERY SYSTEM1Cleared 510(K)
- K001878WATER PURIFIER1Cleared 510(K)
- K001445SMILIE PC1Cleared 510(K)
- K001541MINICAM1Cleared 510(K)
- K000837PUMA DENTAL CHAIR AND UNIT1Cleared 510(K)
- K000799BELMONT UNIT, MODEL 2000 SERIES1Cleared 510(K)
- K000577YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL CAMERA1Cleared 510(K)
- K0009683181 DUO DELIVERY SYSTEM1Cleared 510(K)
- K0009664631 DUO DELIVERY SYSTEM1Cleared 510(K)
- K0009674635 ASSISTANT'S INSTRUMENTATION1Cleared 510(K)
- K000112ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A104011Cleared 510(K)
- K000941STERLTECH WATER PURIFIER1Cleared 510(K)
- K992195QUANTEC-E IRRIGATION SYSTEM 21Cleared 510(K)
- K992893DENTAPURE DP 90 CARTRIDGE, DENTAPURE DP 365 CARTRIDGE1Cleared 510(K)
- K992868DENTAPURE DP40 CARTRIDGE1Cleared 510(K)
- K991946ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L1Cleared 510(K)
- K991098DIFOTI SYSTEM1Cleared 510(K)
- K991035QUANTEC-E IRRIGATION SYSTEM1Cleared 510(K)
- K991011ORASCOPE1Cleared 510(K)
- K990844STARDENTAL AXCS STERILE WATER SYSTEM1Cleared 510(K)
- K990479HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR1Cleared 510(K)
- K991161HYDRO-CAST ACRYLIC VARNISH, MODEL 781251Cleared 510(K)
- K984332SPECTRA VU 1000 SERIES INTRAORAL CAMERA, SPECTRA VU 2000 SERIES INTRAORAL CAMERA, SPECTRA VU HDDI SV I INTRAORAL CAMERA,1Cleared 510(K)
- K990948S575 INTRAORAL DOCKING DENTAL CAMERA1Cleared 510(K)
- K984641FLEXISCOPE OPTOMODUL1Cleared 510(K)
- K984584AIR TECHNIQUES' DENTO-VAC1Cleared 510(K)
- K984609ADEC DENTAL UNIT, MODELS CENTURY PLUS & CASCADE, DCI DENTAL UNIT, MODEL SERIES III1Cleared 510(K)
- K984556SCICAN CLASSIC1Cleared 510(K)
- K984013PLANMECA INTRACAM STATION1Cleared 510(K)
- K983739OPTUM, INTRAORAL CAMERA SYSTEM1Cleared 510(K)
- K983661BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES1Cleared 510(K)
- K983625S555 INTRAORAL DENTAL CAMERA1Cleared 510(K)
- K983735PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE1Cleared 510(K)
- K983731PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE1Cleared 510(K)
- K983242SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES1Cleared 510(K)
- K981171ERADIC-ALL1Cleared 510(K)
- K983847MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT1Cleared 510(K)
- K983285ENGLE DENTAL FAMILY OF DELIVERY SYSTEMS1Cleared 510(K)
- K973765BIO-20001Cleared 510(K)
- K982658KSEA ENDOSCOPES FOR DENTAL PROCEDURES1Cleared 510(K)
- K981565BIOCLEAR CONCENTRATE1Cleared 510(K)
- K973410ULTRACAM1Cleared 510(K)
- K982480PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.1Cleared 510(K)
- K981144CLEAN SOURCE I, MODEL CS10001Cleared 510(K)
- K982117FLUID CONTROL1Cleared 510(K)
- K981937WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM1Cleared 510(K)
- K980049BONETRAP1Cleared 510(K)
- K981663DIGITAL DOC1Cleared 510(K)
- K980106THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES1Cleared 510(K)
- K981534VIPERCAM1Cleared 510(K)
- K982009ONE WEEK BACKSTOP DENTAL ANTI-RETRACTION CHECK VALVE1Cleared 510(K)
- K980577PRINCESS SYRINGE1Cleared 510(K)
- K980474TELICAM1Cleared 510(K)
- K974487SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 20201Cleared 510(K)
- K974542TRUE VISION, TRUE VISION II1Cleared 510(K)
- K974238DENTAL TRAY, STERILE, DISPOSABLE1Cleared 510(K)
- K973996CLEARLINE PLUS, DENTAL WATERLINE FILTER1Cleared 510(K)
- K974204VISTACAM OMNI AND VIASTCAM OMNI (IC)1Cleared 510(K)
- K964271IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID1Cleared 510(K)
- K973492DENTALVIEW PERIOVIEW SYSTEM1Cleared 510(K)
- K973035VIOLA II DENTAL CAMERA SYSTEM1Cleared 510(K)
- K971727DCI WATER PURIFIER1Cleared 510(K)
- K972019PEFECT SHOT1Cleared 510(K)
- K971278PURE COMPANY FLUID DELIVERY SYSTEM1Cleared 510(K)
- K972033PLANMECA INTRACAM1Cleared 510(K)
- K964942INFECTION CONTROL CARTRIDGE1Cleared 510(K)
- K971100ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR1Cleared 510(K)
- K964796ODYSSEY I DENTAL WATER UNIT1Cleared 510(K)
- K970626EASY CAM1Cleared 510(K)
- K970002STERILE WATER PUMP1Cleared 510(K)
- K964619DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)1Cleared 510(K)
- K963548DENTAPURE DENTAL UNIT WATER LINE FILTER-IODINATED1Cleared 510(K)
- K963778CDR-CAM1Cleared 510(K)
- K961420PROSTYLE COMPACT1Cleared 510(K)
- K962665A-DEC SELF-CONTAINED WATER SYSTEM1Cleared 510(K)
- K962071SPIRIT S1/S21Cleared 510(K)
- K962527GENERAL PURPOSE DENTAL TRAY1Cleared 510(K)
- K961409PORTA'PURE/DENTAL1Cleared 510(K)
- K960556BACSTOP DENTAL ANTI-RETRACTION CHECK VALVE1Cleared 510(K)
- K954471POWERS ANTI-BACTERIAL VALVE1Cleared 510(K)
- K960506A-DEC PERFORMER CONTROL UNIT1Cleared 510(K)
- K953912JACOBYSCOPE1Cleared 510(K)
- K951074STOMAVISION (STV)1Cleared 510(K)
- K951238SAFE-TIPS EZ1Cleared 510(K)
- K951019INTRAORAL VIDEO SCOPE AND WINDOW TUBE1Cleared 510(K)
- K950175THE AQUA-AIR PROFESSIONAL FIELD UNIT(S)1Cleared 510(K)
- K942698VACSTAR1Cleared 510(K)
- K943204VISTACAM1Cleared 510(K)
- K946187SPIRIT II AND SPIRIT TREATMENT CENTER1Cleared 510(K)
- K944271DENTAL OPERATIVE UNIT ACCESORIES1Cleared 510(K)
- K944256OKTAS INTRA-ORAL DENTAL CAMERA1Cleared 510(K)
- K942520E-VAC-U-ACCESSORIES1Cleared 510(K)
- K941476MODEL 2600 PROCART1Cleared 510(K)
- K941716MICRODONTIC LENS1Cleared 510(K)
- K940864DENTIST WITH ASSISTANT PACK1Cleared 510(K)
- K941349DENTAL TRAY1Cleared 510(K)
- K934500METASYS AMALGAM SEPARATOR MST11Cleared 510(K)
- K940893A-DEC RADIUS 2122/21321Cleared 510(K)
- K941452ULTRACAM II1Cleared 510(K)
- K934436SBP DENTAL UNIT1Cleared 510(K)
- K934783KAVO INTRASEPT 9051Cleared 510(K)
- K940599DUAL AIR/WATER FILTER CARTRIDGE HANDLE KIT1Cleared 510(K)
- K935325A-DEC CASCADE 3072 WALLMOUNT1Cleared 510(K)
- K933671ULTRACAM1Cleared 510(K)
- K932873SEAC MOBILE UNIT BY ASI MEDICAL1Cleared 510(K)
- K930144THE SCITECH ONE-DAY FILTER1Cleared 510(K)
- K934002PERIO/ENDO LENS1Cleared 510(K)
- K934815AIR COMPRESSOR, MODEL PAC 6.71Cleared 510(K)
- K931093QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE1Cleared 510(K)
- K922649ACE BASIC DENTAL IMPLANT PACK II1Cleared 510(K)
- K922652ACE BASIC DENTAL IMPLANT PACK I1Cleared 510(K)
- K922651ACE DENTAL IMPLANT KIT1Cleared 510(K)
- K922650ACE DENTAL IMPLANT CUSTOM SURGICAL PACK1Cleared 510(K)
- K932878PRECISION INTRA-ORAL SCOPES1Cleared 510(K)
- K925798A-DEC 2545 DUO IC MICRO-CART1Cleared 510(K)
- K925797A-DEC 2544 DOCTORS IC MICRO-CART1Cleared 510(K)
- K933166A-DEC 2611 ASSISTANT'S CART1Cleared 510(K)
- K933167A-DEC 2912 DUO CART1Cleared 510(K)
- K933168A-DEC 3127 ASSISTANT'S WALLMOUNT1Cleared 510(K)
- K933165A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION)1Cleared 510(K)
- K933163A-DEC 2612 ASSISTANT'S CART1Cleared 510(K)
- K923354PORT OPII, PORT OPIII1Cleared 510(K)
- K932824EVACUATOR, ORAL CAVITY1Cleared 510(K)
- K922942PRO-SCOPE MODEL # PS-40001Cleared 510(K)
- K925967MEDCAM1Cleared 510(K)
- K931204AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)1Cleared 510(K)
- K922985CLEAN UP1Cleared 510(K)
- K925829WAGGONER DENTAL MANUFACTURING STERIWATER SYSTEM1Cleared 510(K)
- K920710AIR MEDICA III1Cleared 510(K)
- K915353MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP1Cleared 510(K)
- K914697MDT/CASTLE PURUS DENTAL UNIT1Cleared 510(K)
- K913464STOMAVISION (STV)1Cleared 510(K)
- K911594ORALCAM1Cleared 510(K)
- K911506MODEL 2100 PORTABLE FIELD UNIT1Cleared 510(K)
- K905401ASEPTIMINI UNIT, ADU-101Cleared 510(K)
- K905011ORAL PHARYNGEAL CLEANSING DEVICE1Cleared 510(K)
- K904948PM2002 CC AND PM2002 EC1Cleared 510(K)
- K903452A-DEC IC CONTROL HEAD1Cleared 510(K)
- K903451A-DEC PAC I PORTABLE UNIT1Cleared 510(K)
- K903453A-DEC IC MICRO-CART1Cleared 510(K)
- K903455A-DEC DECADE CUSPIDOR1Cleared 510(K)
- K901806SUCTION ORA-SWAB(R) BRUSH KIT1Cleared 510(K)
- K901672RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT1Cleared 510(K)
- K896532DENTAL DELIVERY SYSTEM1Cleared 510(K)
- K895876RAMVAC DENTAL VACUUM SYSTEM1Cleared 510(K)
- K895877RAMCLEAN DENTAL VACUUM LINE CLEANER1Cleared 510(K)
- K894058ISODENT1Cleared 510(K)
- K894061STUDIO UNO1Cleared 510(K)
- K894759ALLPAC(TM) MATERIAL1Cleared 510(K)
- K893219MATRX DENTAL UNIT1Cleared 510(K)
- K891006QUICK-TIP (DENTAL OPERATORY UNIT)1Cleared 510(K)
- K884219BRACKET TABLE ARM COVER1Cleared 510(K)
- K885299SANI-SLEEVE DRAPE FOR DENTAL USE1Cleared 510(K)
- K882526DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.1Cleared 510(K)
- K883904APOLLO VS, VT, VR 1000/1500, FREEDOM HS, HT, HR1Cleared 510(K)
- K883775PORTABLE II DENTAL DELIVERY SYSTEM1Cleared 510(K)
- K882810EASY-OP, PORTABLE DENTAL CART1Cleared 510(K)
- K861601DP32 HAND HELD DENTAL PROPHYLAXIS UNIT1Cleared 510(K)
- K863021CM-II, CM-I WATER UNIT1Cleared 510(K)
- K863010EUROCART SR-4, EUROCART M-IV, ISOCART III1Cleared 510(K)
- K863023CABINET II AUXILIARY UNIT1Cleared 510(K)
- K854643SOLAR1Cleared 510(K)
- K854642SOLAR CART1Cleared 510(K)
- K854641SOLAR F1Cleared 510(K)
- K852816FREEDOM LINE LUBRICATED MODELS LS-2-5, LT-6-101Cleared 510(K)
- K852524SATALEC SERVOTORQUE S2 SX21Cleared 510(K)
- K851136TROPHY COMPACT - DENTAL UNIT1Cleared 510(K)
- K842357PM 2000 DENTAL UNIT1Cleared 510(K)
- K832673SATELEC PROPHY UNIT PU-20001Cleared 510(K)
- K823230STERILE WATER SYSTEM1Cleared 510(K)
- K823180SA-21 DENTAL UNIT1Cleared 510(K)
- K823133AIR FLOW I1Cleared 510(K)
- K813106PORT-OP1Cleared 510(K)
- K801975LITTLE GIANT I & II HANDPIECE CONTROL1Cleared 510(K)
- K801685SPACELINE DENTAL CHAIR-UNIT1Cleared 510(K)
- K801534LARES AIR PRESSURE GAUGE1Cleared 510(K)
- K800395ARISTOSURG 2501Cleared 510(K)
- K790112MOBILE UNITS, I,II,III,IV1Cleared 510(K)
- K781882MODULAT DENTAL SYSTEMS1Cleared 510(K)
- K781114ULTRAMATE 9901Cleared 510(K)
- K771890PERCEPTION SERIES DELIVERY SYS.1Cleared 510(K)
- K771252CB600, TURBINE CONTROL BOL1Cleared 510(K)
- K771251HU:500, HYGIENASSIST1Cleared 510(K)
- EIEDam, Rubber1Product Code
- EIHPowder, Porcelain2Product Code
- EJEFrame, Rubber Dam1Product Code
- EJGForceps, Rubber Dam Clamp1Product Code
- EJISyringe, Cartridge2Product Code
- EJQWheel, Polishing Agent1Product Code
- EJRAgent, Polishing, Abrasive, Oral Cavity1Product Code
- JEQToothbrush, Powered1Product Code
- JESFloss, Dental1Product Code
- JETPick, Massaging1Product Code
- JEWTip, Rubber, Oral Hygiene1Product Code
- KCQTube Impression And Matrix1Product Code
- KHRAbsorber, Saliva, Paper1Product Code
- KLCChair, Dental, With Operative Unit1Product Code
- KMTTray, Fluoride, Disposable1Product Code
- KOJAirbrush2Product Code
- KOKSterilizer, Endodontic Dry Heat3Product Code
- LCNScraper, Tongue1Product Code
- MAUEraser, Dental Stain1Product Code
- MCFUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile1Product Code
- MMDToothbrush, Ionic, Battery-Powered1Product Code
- NOBUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile1Product Code
- NRDUnit, Operative Dental, Accessories1Product Code
- NRUChair, Dental, Without Operative Unit1Product Code
- NXVDiagnostic Light, Soft Tissue Detector2Product Code
- NXZDental Hygiene Kit1Product Code
- PIPProphy Powder, Airbrush Accessory2Product Code
- OFXGeneral Purpose Dental Tray1Product Code
- PFLIntraoral, Dental Foam Protector1Product Code
- QGOComposite Resin Warmer1Product Code
- QIAPowered Tongue Scraper1Product Code
- QJCPlaque Disclosing Agent1Product Code
- QMJPowered Radiofrequency Toothbrush2Product Code
- QNFLaser Activator For Polymerization2Product Code
- QYJDental Waterline Treatment Cartridge1Product Code
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- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
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- RadiologyReview Panel
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- UnknownReview Panel
K3
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K183347
- 510(k) Type
- Traditional
- Applicant
- Osstem Implant Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/4/2019
- Days to Decision
- 275 days
- Submission Type
- Summary