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
- 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
- K200881Oral-B iO Test Drive Power Brush Trial Program Kit1Cleared 510(K)
- K141018ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT1Cleared 510(K)
- K061351ORAL-B SONIC COMPLETE1Cleared 510(K)
- K061199ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES1Cleared 510(K)
- K040416SONICARE ADVANCE TOOTHBRUSH, MODEL 49001Cleared 510(K)
- K022900BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES1Cleared 510(K)
- K012914SONICWAVE SONIC PLAQUE REMOVER1Cleared 510(K)
- K970381POWERED TOOTHBRUSH1Cleared 510(K)
- K943942TRAV-LER KIT1Cleared 510(K)
- K945248HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH1Cleared 510(K)
- K944084JENERIC/PENTRON P0WERED TOOTHBRUST1Cleared 510(K)
- K942634PEMBUSH1Cleared 510(K)
- K941209MY BEAT POWERED TOOTHBRUSH1Cleared 510(K)
- K941243ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH1Cleared 510(K)
- K940288WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT1Cleared 510(K)
- K935150SONIPLAK1Cleared 510(K)
- K935149SONIBRUSH1Cleared 510(K)
- K935148SONIFLOSS1Cleared 510(K)
- K936076ORAL EASE AUTOMATIC FLOSSER/POWER BRUSH1Cleared 510(K)
- K935561INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT1Cleared 510(K)
- K933829PULSE ELECTRIC TOOTHBRUSH1Cleared 510(K)
- K931360ELECTRIC TOOTH-BRUSH1Cleared 510(K)
- K926247OMRON TRAVEL TOOTHBRUSH/PLAQUE REMOVER #HT-B0051Cleared 510(K)
- K926246OMRON RECHARGEABLE PLAQUE REMOVAL SYSTEM #HT-B1421Cleared 510(K)
- K913724SONEX ULTRASONIC TOOTH BRUSH1Cleared 510(K)
- K924739THE DENTIST'S TOOTH POLISHER1Cleared 510(K)
- K921773TX ELECTRIC TOOTHBRUSH1Cleared 510(K)
- K920644F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND1Cleared 510(K)
- K914198POWER FLOSS AND BRUSH EW 129 & EW 1201Cleared 510(K)
- K910610INTERPLAK HOME PLAQUE REMOVAL INSTRUMENT1Cleared 510(K)
- K903488MERIDIEN DENTAL SYSTEMS1Cleared 510(K)
- K904401BATTERY-POWERED TOOTHBRUSH1Cleared 510(K)
- K903510MICKEY/MINNIE MOUSE BATT. OPERATE TOOTHBRUSH1Cleared 510(K)
- K901963OMRON TRAVEL TOOTHBRUSH, MODEL HT-B021Cleared 510(K)
- K900766EPI DENT TOOTHBRUSH1Cleared 510(K)
- K896245PLAK TRAC POWERED TOOTHBRUSH1Cleared 510(K)
- K893736HOT BRUSH1Cleared 510(K)
- K891694THE SMILE MACHINE1Cleared 510(K)
- K880589ROTA-DENT TOOTH CLEANER1Cleared 510(K)
- K871929PROBRIGHT TOOTH POLISHER1Cleared 510(K)
- K871406THE WOOG ORABRUSH1Cleared 510(K)
- K862224THE WOOG AND THE WOOG D. POWERED TOOTHBRUSHES1Cleared 510(K)
- K860264SCHERER PORTABLE TOOTH POLISHER1Cleared 510(K)
- K854326NO FLOSS FLOSSER1Cleared 510(K)
- K852476INTERPLAK1Cleared 510(K)
- K852279SUNBEAM RECHARGEABLE TOOTHBRUSH MODEL # 42011Cleared 510(K)
- K850562FLOSSAGE - ELECTRIC TOOTHFLOSSER1Cleared 510(K)
- K820537ULTRASONIC TOOTHBRUSH1Cleared 510(K)
- K820503SVENSK TK/21Cleared 510(K)
- K810805WATER PIK AUTOMATIC TOOTHBRUSH1Cleared 510(K)
- K810666BRAUN TRAVEL1Cleared 510(K)
- K780360MASSAGER, GUM/SSAGE POWERED GUM1Cleared 510(K)
- K770997PRO-CARE1Cleared 510(K)
- K770116PORTA-PRO TOOTH POLISHER1Cleared 510(K)
- 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
- 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
THE SMILE MACHINE
- Page Type
- Cleared 510(K)
- 510(k) Number
- K891694
- 510(k) Type
- Traditional
- Applicant
- BRILLIANT INDUSTRIES, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/16/1989
- Days to Decision
- 86 days