Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- LTGPaste, Injectable For Vocal Cord Augmentation3Product Code
- LWMDevice, Electrical Dental AnesthesiaUProduct Code
- MCLKit, Test, In Vitro Periodontal3Product Code
- MQCMouthguard, PrescriptionUProduct Code
- MVLCord, RetractionUProduct Code
- KJJCleanser, Root CanalUProduct Code
- LFDSaliva, ArtificialUProduct Code
- LMWSolution, Removal, Carries3Product Code
- LPGMaterial, Dressing, Surgical, Polylactic Acid3Product Code
- LQYLocator, Root ApexUProduct Code
- NSJRestoration, Noble MetalNProduct Code
- NSKDentures, PartialNProduct Code
- NSLDentures, FullNProduct Code
- NSMRestoration, ResinNProduct Code
- NSNRestoration, Resin, Crown And BridgeNProduct Code
- NSORestoration, Porcelain-Fused-To-MetalNProduct Code
- NSPRestoration, PorcelainNProduct Code
- NSQRestoration, Base MetalNProduct Code
- NSRProsthesis, OrthodonticNProduct Code
- NXJDenture, Cosmetic OnlyNProduct Code
- OBRMouthguard, Over-The-CounterUProduct Code
- OCOMouthguard, Migraine/Tension HeadacheUProduct Code
- OLROral Wound DressingUProduct Code
- OLSOral Wound Dressing W/Drug And/Or BiologicUProduct Code
- PKJCrown And Bridge Material, Resin BasedNProduct Code
- QUAIntraoral Cooling Device2Product Code
- SBCDental Image Analyzer2Product Code
- QJXCaries Detection Product With Drug Or Biologic3Product Code
- SGQIntraoral Phototherapy Device2Product Code
- Submissions with No Product CodeMiscellaneous
- K896826SULTAN PERIO-SELECT IRRIGATION SYSTEMCleared 510(K)
- K863834EVIDENT MARK 2 APEX LOCATORCleared 510(K)
- K863011DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-IICleared 510(K)
- K863012MINILAX SETCleared 510(K)
- K863014ISOPRAT F-III SET/ISOLAX CHAIRCleared 510(K)
- K863007EUROFLEX F-IV, ISOFLEX IIICleared 510(K)
- K863015ISOPRAT C-III SET/ISOCART III AUXILIARY UNITCleared 510(K)
- K863013ISOLAX PEDAL SETCleared 510(K)
- K863017ISOLAX (GNATUS)/ISOLAX PEDAL/MINILAXCleared 510(K)
- K863018DENTATUS-S / L / LS / (GNATUS)Cleared 510(K)
- P050053INFUSE BONE GRAFTAPPRPMA Approval
- K854700EZ-ON TUBING CONDITIONER (LUBRICANT)Cleared 510(K)
- K852926DENTOLOCK II DENTURE ADHESIVE CREAMCleared 510(K)
- K853016STILLE ANGULAR RONGEUR, 8-3/4 SS 410Cleared 510(K)
- K852024DENTIN ADHESIVECleared 510(K)
- K852474UNION BROACH BLEACHING LIGHTCleared 510(K)
- K851841IMAX PERIOTIPSCleared 510(K)
- K843049CURING LIGHTCleared 510(K)
- K844467OMS CRYOCleared 510(K)
- K842371LEE SYRINGECleared 510(K)
- K844667DIXON SCISSORS, STARINLESS STEEL, OPERATING TYPECleared 510(K)
- K842359AUTOMATIC PATIENT CHAIR PM2000 & ACleared 510(K)
- K840652PRISM-FINECleared 510(K)
- K842512EXACTA-FILMCleared 510(K)
- K833635BIOSONICS SALIVARY TESTERCleared 510(K)
- K833592X-BEAM FILM 3TCCleared 510(K)
- K832371EGS MODEL 300Cleared 510(K)
- K832370EGS MODEL 100-2Cleared 510(K)
- K831000MEDION MI-200 IONTOPHORETIC MEDICATORCleared 510(K)
- K831344DIFFERENTIA/DIAGNOSTIC OCCLUSA/APPLIANCCleared 510(K)
- K831039COMPLUS VARIOUS FORMSCleared 510(K)
- K823136ORAL SPONGECleared 510(K)
- K823413MOUTH CARE KIT W/TOOTHBRUSHCleared 510(K)
- K830111SEPTOCALCleared 510(K)
- K830031ACRYLIC SHEET, PLEXIGLASS MCCleared 510(K)
- K823317DENTAL INSTRUMENTS - EXPLORERSCleared 510(K)
- K821783BEACH SILICATE FILLING & LINING APPLIC.Cleared 510(K)
- K820892BOSWORTH WOODEN WEDGESCleared 510(K)
- K820789CANCAN 2002 DENTAL PATIENT CHAIRCleared 510(K)
- K820501ORX DENT-AIDE DENTAL EMERGENCY KITCleared 510(K)
- K811995FORAMATRON APICAL FORAMEN LOCATORCleared 510(K)
- K811210YOSHIDA-PANOURA 10Cleared 510(K)
- K811519K-FLEXCleared 510(K)
- K810656SR-IVOSEAL(SOFT RELINING)Cleared 510(K)
- K803269CAPSULE DENTAL AMALGAMCleared 510(K)
- K802262COMPOSITE RESTORATIVECleared 510(K)
- K801684ASTRON AIR POWERED HIGH SPEED DE PIECECleared 510(K)
- K800520DENTAL STOOLS, #'S P2212, P1121, ETC.Cleared 510(K)
- K792632STERILIZATION PROCESS/BULB SYRINGECleared 510(K)
- K781351AURO-BRUSHCleared 510(K)
- K780849DENTROL LIQUID DENTURE ADHESIVECleared 510(K)
- K771881REPLICA BONDING AGENTCleared 510(K)
- K771400IMPREGNATED DENTAL FLOSSCleared 510(K)
- K770545DURA-VACCleared 510(K)
- K770368ORAL IRRIGATORCleared 510(K)
- K770172PELLET, CALIBRATIONCleared 510(K)
- K770159NEYDIUM NPFLUX (FOR SOLDERING)Cleared 510(K)
- K761276DENTAL STOOLCleared 510(K)
- K761101NEY VIBRATORCleared 510(K)
- K761102NEY-LITECleared 510(K)
- K761067DENTSPLY DIE STONECleared 510(K)
- K760798FLUOCAL GEL MINTCleared 510(K)
- K760799FLUOCAL GEL ORANGECleared 510(K)
- K760988DENTAL HANDPIECESCleared 510(K)
- K760515DISC THINNER, WILL-CERUM LIQUIDCleared 510(K)
- K760514DISC, WILL-CERUM LIQUIDCleared 510(K)
- K760321CHAIR, DENTAL OPERATIVECleared 510(K)
- K760121IMPULSE HEAT SEALERCleared 510(K)
- 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
- 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
PRISM-FINE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K840652
- 510(k) Type
- Traditional
- Applicant
- DENTSPLY INTL.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/2/1984
- Days to Decision
- 169 days