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
- DZJDriver, Wire, And Bone Drill, Manual2Product Code
- DZKWire, Fixation, Intraosseous2Product Code
- DZLScrew, Fixation, Intraosseous2Product Code
- DZMNeedle, Dental1Product Code
- DZNInstruments, Dental Hand1Product Code
- DZPInstrument, Diamond, Dental1Product Code
- DYXLock, Wire, And Ligature, Intraoral2Product Code
- DZADrill, Dental, Intraoral1Product Code
- DZHSaw, Bone, Ac-Powered2Product Code
- DZIDrill, Bone, Powered2Product Code
- EAXMirror, Mouth1Product Code
- EAYLight, Fiber Optic, Dental1Product Code
- EAZLight, Operating, Dental1Product Code
- EBALight, Surgical Headlight1Product Code
- EBWController, Foot, Handpiece And Cord1Product Code
- ECBUnit, Syringe, Air And/Or Water1Product Code
- ECPInstrument, Ligature Tucking, Orthodontic1Product Code
- ECQAligner, Bracket, Orthodontic1Product Code
- ECRSetter, Band, Orthodontic1Product Code
- ECSPusher, Band, Orthodontic1Product Code
- ECTDriver, Band, Orthodontic1Product Code
- EFAHandpiece, Belt And/Or Gear Driven, Dental1Product Code
- EFBHandpiece, Air-Powered, Dental1Product Code
- K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)1Cleared 510(K)
- K251389High speed air turbine handpiece1Cleared 510(K)
- K242179Synea Fusion Handpieces (Intensiv & Profin)1Cleared 510(K)
- K240337Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)1Cleared 510(K)
- K241074High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)1Cleared 510(K)
- K241880Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)1Cleared 510(K)
- K233122High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)1Cleared 510(K)
- K233308Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)1Cleared 510(K)
- K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors1Cleared 510(K)
- K232243EVO 700 series high speed handpiece1Cleared 510(K)
- K230888Titanium Turbine1Cleared 510(K)
- K221741TRAUS Air Dental Handpiece1Cleared 510(K)
- K202674Medidenta High Speed Handpieces1Cleared 510(K)
- K212910Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece1Cleared 510(K)
- K221548Dental Air Polishing Handpiece1Cleared 510(K)
- K221814OK Handpiece1Cleared 510(K)
- K203791Stainless Turbine1Cleared 510(K)
- K202371Highspeed Airturbine Handpiece1Cleared 510(K)
- K202786Dental Low-speed Handpieces and Accessories1Cleared 510(K)
- K193264Disposable High Speed Air Turbine Handpiece1Cleared 510(K)
- K181691High-speed air turbine handpiece / Low-speed air turbine handpiece1Cleared 510(K)
- K190509Lubrina 21Cleared 510(K)
- K192409Midwest Rhino XE and Air Motor M1Cleared 510(K)
- K192412SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece1Cleared 510(K)
- K190508EVO 450 series High Speed Handpieces1Cleared 510(K)
- K181900Dental high speed handpiece, Dental low speed handpiece1Cleared 510(K)
- K181110PROPHYflex 41Cleared 510(K)
- K173943Dental High-speed Handpiece and Accessories1Cleared 510(K)
- K172543High-speed Turbine Handpieces for Single Use1Cleared 510(K)
- K173465Concentrix MX-AC High-Speed Handpiece1Cleared 510(K)
- K171174PERIO-FLOW nozzle1Cleared 510(K)
- K171553W&H Assistina Twin1Cleared 510(K)
- K170236Dental Low-speed Turbine Handpiece1Cleared 510(K)
- K170229Dental High-speed Turbine Handpiece1Cleared 510(K)
- K170261Premium Plus Prophy Air Motor1Cleared 510(K)
- K163483PANA SPRAY Plus1Cleared 510(K)
- K162926Air-Powered Handpieces and Handpiece Attachments1Cleared 510(K)
- K160410WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head1Cleared 510(K)
- K153411430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece1Cleared 510(K)
- K151912AIR-FLOW handy 3.0 PLUS1Cleared 510(K)
- K152146High Speed Handpieces and Accessories1Cleared 510(K)
- K143704Advanced Air System1Cleared 510(K)
- K141886MDK HANDPIECES1Cleared 510(K)
- K141576Maxima PRO 45L1Cleared 510(K)
- K150798Codent Low Speed Dental Handpieces and Accessories1Cleared 510(K)
- K141183EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES1Cleared 510(K)
- K143183Maxima XTEND Handpiece Maintenance System1Cleared 510(K)
- K142063#8C RENEGADE DENTAL HANDPIECE1Cleared 510(K)
- K141221LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR1Cleared 510(K)
- K133069CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES1Cleared 510(K)
- K131319T1/T2/T3 TURBINE FAMILY1Cleared 510(K)
- K132478AIR-FLOW HANDY 3.01Cleared 510(K)
- K133170QUICK JET M1Cleared 510(K)
- K132480AIR-FLOW HANDY 3.0 PERIO1Cleared 510(K)
- K130560MASTERTORQUE LUX 8900 L1Cleared 510(K)
- K130455430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES1Cleared 510(K)
- K131014PANA SPRAY PLUS1Cleared 510(K)
- K120218TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE)1Cleared 510(K)
- K112024TI-MAX X4501Cleared 510(K)
- K113674SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT1Cleared 510(K)
- K113655TI-MAX X TURBINE1Cleared 510(K)
- K113222ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE1Cleared 510(K)
- K111249ORTHOSLENDERIZER1Cleared 510(K)
- K112673PROPHY-MATE NEO1Cleared 510(K)
- K113301CONCENPIECE,HIGH-SPEED HANDPIECE SERIES1Cleared 510(K)
- K112869EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 4001Cleared 510(K)
- K112623AIRLIGHT DENTAL HANDPIECE1Cleared 510(K)
- K110379AIR-N-GO1Cleared 510(K)
- K102517TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS1Cleared 510(K)
- K100731BOSWORTH AIR POLISHER1Cleared 510(K)
- K101551PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M1Cleared 510(K)
- K101717DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING1Cleared 510(K)
- K100389HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT1Cleared 510(K)
- K100833SYLE SMARTIP1Cleared 510(K)
- K093971DENTAL HANDPIECE1Cleared 510(K)
- K093341CENTURY MODEL 105C1Cleared 510(K)
- K092933SAF (SELF ADJUSTING FILE)1Cleared 510(K)
- K093072STARCARE HANDPIECE MAINTENANCE UNIT1Cleared 510(K)
- K093084ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP1Cleared 510(K)
- K092289EMS AIR-FLOW HANDY PERIO1Cleared 510(K)
- K091065AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP41Cleared 510(K)
- K090548CONTRA-ANGLE HANDPIECE KOMET OS301Cleared 510(K)
- K090369PRODRIVE LINE OF DENTAL HANDPIECES1Cleared 510(K)
- K083101PREMIUM SLOW SPEED; 20K AIR MOTOR, HEADS, CONTRA-ANGLES, STRAIGHT NOSECONES1Cleared 510(K)
- K082791EMS AIR-FLOW MASTER1Cleared 510(K)
- K081811CARE3 PLUS1Cleared 510(K)
- K082716A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-431Cleared 510(K)
- K082827A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT1Cleared 510(K)
- K080682HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE1Cleared 510(K)
- K073478SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS1Cleared 510(K)
- K073652ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE1Cleared 510(K)
- K080240CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE1Cleared 510(K)
- K073319STATMATIC 31 HANDPIECE MAINTENANCE UNIT1Cleared 510(K)
- K072989AXIS SYSTEM1Cleared 510(K)
- K072754AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE1Cleared 510(K)
- K073284AIR-FLOW MASTER STANDARD1Cleared 510(K)
- K073353DO-ALL DENTAL HANDPIECE LUBRICANT1Cleared 510(K)
- K072554ACCESS AND ROTAMAX FIBER OPTIC HIGH SPEED DENTAL HANDPIECES1Cleared 510(K)
- K071561HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D1Cleared 510(K)
- K071891STATIS DENTAL HANDPIECES1Cleared 510(K)
- K071965I-SURGE1Cleared 510(K)
- K070663A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT1Cleared 510(K)
- K070869PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 2644221Cleared 510(K)
- K070074LUBRINA, MODEL HIM-11Cleared 510(K)
- K070297CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT1Cleared 510(K)
- K070001MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE, TM5 LOW SPEED HANDPIECE AND TM20 LOW SPEED HANDPIECE1Cleared 510(K)
- K070155INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC1Cleared 510(K)
- K062947HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES1Cleared 510(K)
- K062812DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N1Cleared 510(K)
- K062740JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU1Cleared 510(K)
- K063110CST61 HIGH SPEED TURBINE HANDPIECE1Cleared 510(K)
- K062418K-SPRAY, MODEL 085-27151Cleared 510(K)
- K062219PRODRIVE SYSTEMS REPLACEMENT TURBINE1Cleared 510(K)
- K053368INTERPROXIMAL REDUCTION SYSTEM1Cleared 510(K)
- K052822DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 2021Cleared 510(K)
- K052700PANA-SPRAY1Cleared 510(K)
- K051872MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS20111Cleared 510(K)
- K043497AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV1Cleared 510(K)
- K043498TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE1Cleared 510(K)
- K042787IS 40 MICROMOTOR1Cleared 510(K)
- K041755CROMAX HIGH SPEED TURBINE HANDPIECE1Cleared 510(K)
- K041141DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G1251Cleared 510(K)
- K033812SIROAIR L AIR SCALER1Cleared 510(K)
- K033213CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS1Cleared 510(K)
- K032395PROPHY-MATE1Cleared 510(K)
- K032234MK-DENT HIGH SPEED DENTAL HANDPIECE, MODELS HS 4021K, 4011K, 4012K, AND HS 6021K, 6011K, 6012K1Cleared 510(K)
- K031851DENTISEPTIC HPC1Cleared 510(K)
- K031145ESTYLUS ELECTRIC MOTOR SYSTEM1Cleared 510(K)
- K031868PROPHYPEARLS1Cleared 510(K)
- K022535MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A1001Cleared 510(K)
- K022119EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE1Cleared 510(K)
- K012308KAVO QUATTROCARE1Cleared 510(K)
- K012720TULSA CONTRA ANGLES1Cleared 510(K)
- K010127W & H ASSISTINA1Cleared 510(K)
- K003518RAPIDD HIGHSPEED DENTAL HANDPIECE1Cleared 510(K)
- K000834CASTELLNI AIR POWERED HANDPIECES SYRINGES: THREE STERIL, MULTISTERIL TURBINS: CLEANAIR, CLEANLIGHT MICROMOTORS: IMPLANTO1Cleared 510(K)
- K000848TDK HANDPIECES1Cleared 510(K)
- K000847ORALUBE1Cleared 510(K)
- K000710MD 10, SEM, SM 12, CBM1Cleared 510(K)
- K000547ATR TECNIKA1Cleared 510(K)
- K000049SUNI MAX1Cleared 510(K)
- K993526SYNEA - LS LOW-SPEED HANDPIECE1Cleared 510(K)
- K971732DENTAL HANDPIECE1Cleared 510(K)
- K991401ATR 3000, ATR 2000, IMPLANT-PRO1Cleared 510(K)
- K991492LC COMPOSITE1Cleared 510(K)
- K992380ENDO-EZE MOTOR AND HANDPIECE1Cleared 510(K)
- K991857AIRFLOW HANDY1Cleared 510(K)
- K992011SYNEA-HS HIGH SPEED-HANDPIECE1Cleared 510(K)
- K991701MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)1Cleared 510(K)
- K984244ORL-E-92 SURGICAL DRILL SYSTEM1Cleared 510(K)
- K981679TCM 3000 AND TCM ENDO1Cleared 510(K)
- K983183GYRO LONG-LIFE,BLACK PEARL ECO, ONDINE &CROMA, PRESTIGE, BORA, AQUILON, MC2,MC3, BASCH, ISOLITE, OPTIMA, US, PLPE, CA, P1Cleared 510(K)
- K983168AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 2001Cleared 510(K)
- K982593LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE1Cleared 510(K)
- K980585MILLENNIUM1Cleared 510(K)
- K982050MODEL MS-2 HANDPIECE1Cleared 510(K)
- K981869PRO-FLEX DISPOSABLE PROPHY ANGLE1Cleared 510(K)
- K981990MRS-400, MAXI 400, MRSL-400, MAXI 400L1Cleared 510(K)
- K980162MACH-SIGMA HANDPIECE, ULTRAPUSH1Cleared 510(K)
- K974670ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE1Cleared 510(K)
- K974671ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR1Cleared 510(K)
- K973876PROPHYFLEX 2, MODEL 20121Cleared 510(K)
- K972436T1 LINE DENTAL HANDPIECES1Cleared 510(K)
- K972375IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE1Cleared 510(K)
- K972376IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE1Cleared 510(K)
- K971774NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION1Cleared 510(K)
- K970104SANI-SHIELD1Cleared 510(K)
- K963843ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT1Cleared 510(K)
- K961275SIRIUS 10, 10L, 40, 40L1Cleared 510(K)
- K961235SIRIUS 180, 180L, 230, 230L1Cleared 510(K)
- K963664DENTAL HANDPIECE AND ACCESSORY1Cleared 510(K)
- K962877MIDWEST 300 SE1Cleared 510(K)
- K963050TRADITION P, PUSH BUTTON HANDPIECE1Cleared 510(K)
- K962542AIR MOTOR HANDPIECE TN-1021Cleared 510(K)
- K962543ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TU1Cleared 510(K)
- K952927IMPACT AIR 45 4-HOLE1Cleared 510(K)
- K961076MM 3241Cleared 510(K)
- K961163LARES RESEARCH AS-1 LOWSPEED HANDPIECE1Cleared 510(K)
- K960541LYNX DPA DISPOSABLE PROPHY ANGLE1Cleared 510(K)
- K955655MIDWEST ONE1Cleared 510(K)
- K960352ALLRAP/SLIP-N-GRIP1Cleared 510(K)
- K955654SHORTSTOP DISPOSABLE PROPHY ANGLE1Cleared 510(K)
- K945256MTC 7707 HIGH SPEED AIR TURBINE1Cleared 510(K)
- K954722MICRO-DISPENSER 7000 & MICRODISPENSER 80001Cleared 510(K)
- K954991PHASE CHANGE DENTAL LUBRICANT1Cleared 510(K)
- K954012DISPOSABLE PROPHY HANDPIECE1Cleared 510(K)
- K945734W&H ROTO QUICK COUPLINGS1Cleared 510(K)
- K944719W&H 100 SERIES LOW SPEED1Cleared 510(K)
- K944718W&H 900 INCOLIGHT LT HANDPIECE1Cleared 510(K)
- K944713W&H MICRO AIR MOTOR LT251Cleared 510(K)
- K944714W&H CORSAIR SCALER1Cleared 510(K)
- K944711W&H AIR MOTOR A251Cleared 510(K)
- K944712W&H MICRO MOTOR E25 (WITHOUT LIGHT)1Cleared 510(K)
- K932333PROTECTORAL ULTRASONIC HANDPIECE PROCESSOR1Cleared 510(K)
- K944709W&H 896 TOP LIGH HIGHSPEED1Cleared 510(K)
- K944716W&H 796 TOP AIR TURBINE MINI-HEAD1Cleared 510(K)
- K944717W&H 798 TOP AIR TURBINE TRIPLE SPRAY1Cleared 510(K)
- K944715W&H 795 TOP AIR TURBINE SINGLE SPRAY1Cleared 510(K)
- K944708W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY1Cleared 510(K)
- K944710W&H 898 TOP LIGHT HIGHSPEED1Cleared 510(K)
- K935676MICRO RSH HIGH SPEED HANDPIECE1Cleared 510(K)
- K923780DENTOOL1Cleared 510(K)
- K940261LYNX LOW-SPEED HANDPIECE1Cleared 510(K)
- K925678ATHENA HIGH SPEED HANDPIECE1Cleared 510(K)
- K942672STERI-LUBE1Cleared 510(K)
- K926155CA AND ST1Cleared 510(K)
- K926154HANDPIECE MODELS: MS-350;RS-350;N-270 AIR-MOTOR1Cleared 510(K)
- K925080TEK-LUBE1Cleared 510(K)
- K932990ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP1Cleared 510(K)
- K925739HIGH SPEED DENTAL DRILL/HANDPIECE1Cleared 510(K)
- K925378STERI-SOL SOLUTION, MODIFICATION1Cleared 510(K)
- K924089OPTI-SHIELD1Cleared 510(K)
- K922437HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-2701Cleared 510(K)
- K923469ORALSAFE1Cleared 510(K)
- K921564POLYCLEAN1Cleared 510(K)
- K912786W-H TOPAIR DENTAL HANDPIECE1Cleared 510(K)
- K911937OSTEOMED IB DRILL1Cleared 510(K)
- K91106829540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM1Cleared 510(K)
- K905542LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS1Cleared 510(K)
- K905541LARES 757 WORKHORSE HIGHSPEED HANDPIECE1Cleared 510(K)
- K905155HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECES1Cleared 510(K)
- K904671QAR HANDPIECE1Cleared 510(K)
- K900798LYNX LOW-SPEED HANDPIECE1Cleared 510(K)
- K901239TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE1Cleared 510(K)
- K900093DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER1Cleared 510(K)
- K897101DISPOSABLE PROPHY ANGLE AND ACCESSORIES1Cleared 510(K)
- K896878HANDPIECE SYSTEM WITH MOTOR (SEVERAL MODELS)1Cleared 510(K)
- K896877DENTAL AIR MOTORS (SEVERAL MODELS)1Cleared 510(K)
- K896879ORAL SURGERY HANDPIECE AND ATTACHMENTS1Cleared 510(K)
- K896876DYNATORQ DENTAL HANDPIECE ATTACHMENTS1Cleared 510(K)
- K896361HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE1Cleared 510(K)
- K895736LYNX-HIGH SPEED HANDPIECE1Cleared 510(K)
- K894606MICRO-AIRE HIGH SPEED DRILL (2910-000)1Cleared 510(K)
- K885115IMD 7GX1Cleared 510(K)
- K890433IMPLANT PARALLELING DEVICE (I.P.D.)1Cleared 510(K)
- K882491CUTTING FLUID SYSTEM FOR DENTAL HIGH SPEED DRILLS1Cleared 510(K)
- K881985CONTRA ANGLE HANDPIECE ATTACH. W/PROPHYLAXIS CUP1Cleared 510(K)
- K881974PROFICIENT(TM) PROPHYLAXIS ANGLE1Cleared 510(K)
- K882135AQUA DENT HANDPIECE EXTENSION AND AQUA DENT DISP.1Cleared 510(K)
- K874294AUTOCHUCK ATTACHMENT1Cleared 510(K)
- K873209PLAQUE-SWEEP1Cleared 510(K)
- K863677TRADITION HIGH SPEED HANDPIECE1Cleared 510(K)
- K854645GOLD AIR, GOLD LIGHT1Cleared 510(K)
- K854697TUBING HANDPIECE REPLACEMENT1Cleared 510(K)
- K850597MICRO-AIRE HIGH SPEED ORAL SURGERG DRILL1Cleared 510(K)
- K840690DENTAL HANDPIECE1Cleared 510(K)
- K821715AM-40 SYSTEM1Cleared 510(K)
- K821484DAWN LOW SPEED HANDPIECE SYSTEM1Cleared 510(K)
- K801535LARES HANDPIECE OIL1Cleared 510(K)
- K801651CUTTER JET1Cleared 510(K)
- K792302LS-1001Cleared 510(K)
- K792304MW-80001Cleared 510(K)
- K790601DENTAL HANDPIECE1Cleared 510(K)
- K790113MIDWEST 10001Cleared 510(K)
- K781545AIR POWERED DENTAL HANDPIECE1Cleared 510(K)
- K780483FIBER OPTIC HANDPIECE1Cleared 510(K)
- K780038DENTAL HANDPIECE1Cleared 510(K)
- K772244ILLUMINATED DENTAL HANDPIECE1Cleared 510(K)
- K760929ACCUTORQ II1Cleared 510(K)
- K760794FIBER OPTICS HIGH SPEED HANDPIECE1Cleared 510(K)
- K760331TURBINE, AIR DRIVEN HANDPIECE (2000)1Cleared 510(K)
- EFKForceps, Articulation Paper1Product Code
- EFLForceps, Dressing, Dental1Product Code
- EGIParallelometer1Product Code
- EGMInjector, Jet, Mechanical-Powered2Product Code
- EGNScissors, Surgical Tissue, Dental1Product Code
- EGQInjector, Jet, Gas-Powered2Product Code
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental1Product Code
- EIBSyringe, Irrigating (Dental)1Product Code
- EICSyringe, Periodontic, Endodontic, Irrigating1Product Code
- EIDSyringe, Restorative And Impression Material1Product Code
- EIFAccessories, Retractor, Dental1Product Code
- EIGRetractor, All Types1Product Code
- EIKCarver, Wax, Dental1Product Code
- EILGauge, Depth, Instrument, Dental1Product Code
- EIRScissors, Collar And Crown1Product Code
- EISRemover, Crown1Product Code
- EIXProbe, Periodontic1Product Code
- EIYInstrument, Filling, Plastic, Dental1Product Code
- EJBHandle, Instrument, Dental1Product Code
- EJYPliers, Operative1Product Code
- EJZKnife, Margin Finishing, Operative1Product Code
- EKAFile, Margin Finishing, Operative1Product Code
- EKBExplorer, Operative1Product Code
- EKCExcavator, Dental, Operative1Product Code
- EKDInstrument, Cutting, Operative1Product Code
- EKECurette, Operative1Product Code
- EKFInstrument, Contouring, Matrix, Operative1Product Code
- EKGCondenser, Amalgam And Foil, Operative1Product Code
- EKHCarver, Dental Amalgam, Operative1Product Code
- EKICarrier, Amalgam, Operative1Product Code
- EKJBurnisher, Operative1Product Code
- EKKSpreader, Pulp Canal Filling Material, Endodontic1Product Code
- EKPReamer, Pulp Canal, Endodontic1Product Code
- EKQPreparer, Root Canal Endodontic1Product Code
- EKRPlugger, Root Canal, Endodontic1Product Code
- EKSFile, Pulp Canal, Endodontic1Product Code
- EKTCurette, Endodontic1Product Code
- EKWBroach, Endodontic1Product Code
- EKXHandpiece, Direct Drive, Ac-Powered1Product Code
- EKYHandpiece, Water-Powered1Product Code
- EKZUnit, Electrosurgical, And Accessories, Dental2Product Code
- ELAInstrument, Hand, Calculus Removal1Product Code
- ELBScaler, Rotary2Product Code
- ELCScaler, Ultrasonic2Product Code
- EMDHemostat, Surgical1Product Code
- EMEPunch, Biopsy, Surgical1Product Code
- EMGForceps, Tooth Extractor, Surgical1Product Code
- EMHForceps, Rongeur, Surgical1Product Code
- EMIFile, Bone, Surgical1Product Code
- EMJElevator, Surgical, Dental1Product Code
- EMKCurette, Surgical, Dental1Product Code
- EMLChisel, Bone, Surgical1Product Code
- EMMChisel, Osteotome, Surgical1Product Code
- EMNScaler, Periodontic1Product Code
- EMOKnife, Periodontic1Product Code
- EMPMarker, Periodontic1Product Code
- EMQHoe, Periodontic1Product Code
- EMRFile, Periodontic1Product Code
- EMSCurette, Periodontic1Product Code
- JEPRetainer, Matrix1Product Code
- JEXPlier, Orthodontic1Product Code
- JEYPlate, Bone2Product Code
- KMWHandpiece, Rotary Bone Cutting2Product Code
- MDLImplant, Transmandibular2Product Code
- MQNExternal Mandibular Fixator And/Or Distractor2Product Code
- MXFSystem, Dental, Hydrokinetic, Caries Removal & Cavity Preparation2Product Code
- NEIProsthesis, Condyle, Mandibular, Temporary2Product Code
- NLDInstrument, Diamond, Dental, Reprocessed1Product Code
- NMWNeedle, Dental, Reprocessed1Product Code
- NYCDental Prophylaxis Kit1Product Code
- NYFGingival Retraction Kit1Product Code
- NYGLapping Tool Kit1Product Code
- NYLHandpiece, Air-Powered, Root Canal Irrigation1Product Code
- PLVDental Stereotaxic Instrument2Product Code
- PWLOral Surgery Tray1Product Code
- NVKLaser, Dental, Soft Tissue2Product Code
- OAJCatheter, Drainage, Intraoral/Extraoral1Product Code
- PEMDental Barriers And Sleeves2Product Code
- QRYDental Navigation System2Product Code
- 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
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ORALUBE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K000847
- 510(k) Type
- Traditional
- Applicant
- Orasystems
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/27/2000
- Days to Decision
- 196 days
- Submission Type
- Statement