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
- 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
- K961714ASEPTYLUM, UNI-CARRIER1Cleared 510(K)
- K953707MEDTROL DENTAL KIT1Cleared 510(K)
- K945815DENTAL KIT1Cleared 510(K)
- K951607SUREFLEX FILES1Cleared 510(K)
- K945077INSTRUMENT,FILLING,PLASTIC,DENTAL1Cleared 510(K)
- K943820STAT PAK1Cleared 510(K)
- K943351MAUNAL DISPOSABLE DENTAL INSTRUMENTS1Cleared 510(K)
- K943584PRESTERILIZED ENDODONTIC FILES1Cleared 510(K)
- K935127SOUTHLAND STERILE DENTAL SYSTEM1Cleared 510(K)
- K941954NON-FOGGING DENTAL MIRROR1Cleared 510(K)
- K925115AMD DENTIST AND HYGIENIST KITS1Cleared 510(K)
- K925890MIRROR, MOUTH1Cleared 510(K)
- K925889FORCEPS, DRESSING, DENTAL1Cleared 510(K)
- K925888EXPLORER, OPERATIVE1Cleared 510(K)
- K935217LC DENTAL HAND INSTRUMENT1Cleared 510(K)
- K932511SILICONE MIRROR1Cleared 510(K)
- K926368APPLICATOR NOZZLE1Cleared 510(K)
- K923902STERILE DENTAL KITS1Cleared 510(K)
- K922988ECO/DENTAL GENERAL DENTAL PACK1Cleared 510(K)
- K921354BLUNT TIP IRRIGATION NEEDLES1Cleared 510(K)
- K914368PART 872 DEGUFILL H & DEGUFILL M DA1Cleared 510(K)
- K911655IMPLARETTE1Cleared 510(K)
- K912473ACCU-PLACER TM KIT1Cleared 510(K)
- K911214NUTIP (TM) SYRINGE SHIELD1Cleared 510(K)
- K912149HARDCOATED PLASTIC FILLING INSTRUMENT1Cleared 510(K)
- K911281PULPDENT PIC N STIC1Cleared 510(K)
- K901053MIRROR SHIELD1Cleared 510(K)
- K901178AMALGAM CONDENSER1Cleared 510(K)
- K901177DISCOID/CLEOID DOUBLE END AMALGAM CARVER1Cleared 510(K)
- K901176#23 EXPLORER1Cleared 510(K)
- K901175HAND MIRROR1Cleared 510(K)
- K901174ELEVATOR #111Cleared 510(K)
- K901173DISCOID SPOON EXCAVATOR1Cleared 510(K)
- K901172GRACEY CURETTE #13-141Cleared 510(K)
- K901171U-15 SINGLE END SCALER1Cleared 510(K)
- K901170PERIODONTAL KNIFE1Cleared 510(K)
- K9011695 STRAIGHT SCISSORS1Cleared 510(K)
- K896843EXPLORER 24 DENTAL HAND INSTRUMENT1Cleared 510(K)
- K896565DMV(R) VENEER SUCTION GRIPPER1Cleared 510(K)
- K895985SANI-PIKS DENTAL HAND INSTRUMENT1Cleared 510(K)
- K895958BREVET FLOSS PICK (AUTOCLAVE STERILIZER)1Cleared 510(K)
- K895959BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)1Cleared 510(K)
- K894895ANSWER DENTAL IMPLEMENTS, MIRROR1Cleared 510(K)
- K894896ANSWER DENTAL IMPLEMENT, EXPLORER1Cleared 510(K)
- K894897ANSWER DENTAL IMPLEMENT, FORCEPS1Cleared 510(K)
- K892239DENTAL HAND INSTRUMENTS1Cleared 510(K)
- K892261RUBBER DAM CLAMPS/FORCEPS1Cleared 510(K)
- K892260PRICHARD PERIOSTEAL RETRACTOR #31Cleared 510(K)
- K884308MANDIBLE MANIPULATOR1Cleared 510(K)
- K890357DENTAL IMPRESSION SYINGE1Cleared 510(K)
- K890064DENTAL SYRINGE APPLICATION TIP1Cleared 510(K)
- K885218DISCARD DENTAL MIRROR1Cleared 510(K)
- K885217DISCARD DENTAL EXPLORER1Cleared 510(K)
- K885219DENTAL DRESSING PLIERS1Cleared 510(K)
- K884653RACESTYPTINE1Cleared 510(K)
- K885162BENDA BRUSH1Cleared 510(K)
- K885040DENTAL MIRROR RETRACTOR1Cleared 510(K)
- K884515BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED1Cleared 510(K)
- K883126BREVET DENTAL INSTRUMENTS1Cleared 510(K)
- K882821VITRABOND LIGHT CURE GLASS IONOMER LINER1Cleared 510(K)
- K883322DENTAL HAND INSTRUMENTS1Cleared 510(K)
- K882651CENTRIX NEEDLETUBE1Cleared 510(K)
- K882834TISSUE PUNCH1Cleared 510(K)
- K881992SYRETTE1Cleared 510(K)
- K882309THE DIRECTION DIAL1Cleared 510(K)
- K882399ASEPTIP1Cleared 510(K)
- K880849EXAMIX DISPENSER1Cleared 510(K)
- K880542DENTALVISION TV SYSTEM1Cleared 510(K)
- K880590DISPOSABLE DENTAL PROBE/EXPLORER1Cleared 510(K)
- K874964DENTAL HAND INSTRUMENTS1Cleared 510(K)
- K874335EXPLORER-DENTAL PROBER1Cleared 510(K)
- K821779BEACH AMALGAM CARRIER, GUN TYPE1Cleared 510(K)
- 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
HARDCOATED PLASTIC FILLING INSTRUMENT
- Page Type
- Cleared 510(K)
- 510(k) Number
- K912149
- 510(k) Type
- Traditional
- Applicant
- PREMIER DENTAL PRODUCTS CO.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/24/1991
- Days to Decision
- 40 days
- Submission Type
- Statement