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
- 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
- K240183Star E900 Handpiece Series1Cleared 510(K)
- K230106General Cutting Straight1Cleared 510(K)
- K222518FX Contra1Cleared 510(K)
- K220874Smooth Drive contra angle and straight handpieces1Cleared 510(K)
- K220346Lotus Prophy Angle1Cleared 510(K)
- K220577Dental Handpiece, Model CA160, CA160L, and CA500L1Cleared 510(K)
- K213139SURGmatic S15 L Pro1Cleared 510(K)
- K202960General Cutting Contra Handpiece1Cleared 510(K)
- K182892TRAUS Dental Handpieces1Cleared 510(K)
- K182999General Cutting Contra Handpiece1Cleared 510(K)
- K181129STRONG Dental Handpieces1Cleared 510(K)
- K171436STRONG Dental Handpieces1Cleared 510(K)
- K162856Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)1Cleared 510(K)
- K162397Titan 3 Low Speed Angle Attachments1Cleared 510(K)
- K133178LUXATOR LX HANDPIECE1Cleared 510(K)
- K143418STRONG Dental Handpieces1Cleared 510(K)
- K150750Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray1Cleared 510(K)
- K141125U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE1Cleared 510(K)
- K132356SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST1Cleared 510(K)
- K121901TI-MAX Z451Cleared 510(K)
- K112305VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES1Cleared 510(K)
- K111541ENDO-EXPRESS (R) HANDPIECE1Cleared 510(K)
- K103697TORQTECH1Cleared 510(K)
- K111532MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE1Cleared 510(K)
- K103158STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER1Cleared 510(K)
- K103157DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE1Cleared 510(K)
- K100854PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 33991Cleared 510(K)
- K100192STRONG DENTAL HANDPIECES1Cleared 510(K)
- K092053MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH1Cleared 510(K)
- K061897EXCEL CONTRA ANGLE HANDPIECE1Cleared 510(K)
- K060317ANTHOGYR CONTRA ANGLES AND HANDPIECES1Cleared 510(K)
- K060377DR DISPOSABLE PROPHY ANGLE MODEL H3101Cleared 510(K)
- K051077E-TYPE STRAIGHT HANDPIECE, MODEL AHP-1011Cleared 510(K)
- K042171AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 501002321Cleared 510(K)
- K032925B&R DEVICE1Cleared 510(K)
- K022505CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,1Cleared 510(K)
- K030603PROANGLE DISPOSABLE PROPHY ANGLE1Cleared 510(K)
- K023953ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE1Cleared 510(K)
- K022264CLEAN 'N' OIL1Cleared 510(K)
- K020137AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON1Cleared 510(K)
- K011061SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-111Cleared 510(K)
- K994024EXTENDED STRAIGHT ATTACHMENT1Cleared 510(K)
- K983574STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS1Cleared 510(K)
- K97380023:1 REDUCTION ANGLE1Cleared 510(K)
- K972569E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION1Cleared 510(K)
- K971350SERIES XE, SERIES SE, SERIES TE1Cleared 510(K)
- K962540E-TYPE CONTRA ANGLE NAC-E1Cleared 510(K)
- K961494SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE1Cleared 510(K)
- K950555J SINGLE USE HEAD AND JD REUSABLE HANDLE1Cleared 510(K)
- K954802RITE-ANGLE DISPOSABLE PROPHY ANGLES1Cleared 510(K)
- K950773PROPHYLAXIS PACK1Cleared 510(K)
- K950743ORAL PROCEDURE PACK1Cleared 510(K)
- K945834PROPHY PRO.1Cleared 510(K)
- K942480M4 CONTRA-ANGLE HANDPIECE1Cleared 510(K)
- K933639IMKB CONTRA-ANGLES1Cleared 510(K)
- K934781BVR HIGH TORQUE HEADS1Cleared 510(K)
- K934571BVR CONTRA-ANGLE HANDPIECE1Cleared 510(K)
- K941009DISPOSABLE PROPHY ANGLE1Cleared 510(K)
- K941189DISPOSABLE PROPHYLAXIS ANGLE1Cleared 510(K)
- K923980Q3 DISPOSABLE PROPHY ANGLE1Cleared 510(K)
- K850294CANAL FINDER1Cleared 510(K)
- K844989FLO-PHORESIS - DESENSITIZER1Cleared 510(K)
- K850344AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG1Cleared 510(K)
- K821686DENSCO PROPHY ANGLE1Cleared 510(K)
- K801688TORX HANDPIECE CONTRA ANGLES ATTACHMENTS1Cleared 510(K)
- K800735U-STYLE ADAPTER1Cleared 510(K)
- K792445MW STRAIGHT ATTACHMENT1Cleared 510(K)
- K790722PROPHYLAXIS ANGLE1Cleared 510(K)
- K780752PROPHYLAXIS ANGLE1Cleared 510(K)
- K780213HANDPIECE, LIFT, ENDO1Cleared 510(K)
- K780199PROPHY ANGLES, R&R1Cleared 510(K)
- 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
PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K100854
- 510(k) Type
- Traditional
- Applicant
- PREMIUM PLUS INTERNATIONAL LIMITED
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/9/2010
- Days to Decision
- 258 days
- Submission Type
- Statement