Anesthesiology
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- ChemistryReview Panel
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- 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
- K130186DENTEK EASY BRUSH WITH FLUORIDE1Cleared 510(K)
- K121165BEAM BRUSH/BEAM APP1Cleared 510(K)
- K102871SILVER CARE ANITBACTERIAL TOOTHBRUSH1Cleared 510(K)
- K073224ORAL-B SUB-BRAND MANUAL TOOTHBRUSH1Cleared 510(K)
- K021383ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL1Cleared 510(K)
- K020776MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS1Cleared 510(K)
- K000290LAZERSMILE, LAZERWHITE1Cleared 510(K)
- K994144TOOTHBRUSH WASH1Cleared 510(K)
- K992435BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER1Cleared 510(K)
- K980995PLAQ-ATAQ-I1Cleared 510(K)
- K974761BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH1Cleared 510(K)
- K973236CREST TOOTHBRUSH WITH MICROSHIELD1Cleared 510(K)
- K971589REACH ANTIBACTERIAL TOOTHBRUSH1Cleared 510(K)
- K955530RANIR HI-TECHNOLOGY DENTAL FLOSS1Cleared 510(K)
- K950993BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH1Cleared 510(K)
- K930869ECO TOOTHBRUSH1Cleared 510(K)
- K905090FEEL FRESH TOOTHBRUSH KIT1Cleared 510(K)
- K901994ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM1Cleared 510(K)
- K892264ORALCHEK SUPER-SOFT BRUSH1Cleared 510(K)
- K882572DOCTOR KOLYNOS TOOTHBRUSH1Cleared 510(K)
- K890812HEADS TRUE BRUSH1Cleared 510(K)
- K883761IONODENT II (6 VOLTS)1Cleared 510(K)
- K874443IONODENT (TOOTHBRUSH)1Cleared 510(K)
- K880485XENEX DENTAL ROULETTE1Cleared 510(K)
- K873317EZ BRUSH & FLOSS1Cleared 510(K)
- K871879SOFSWAB1Cleared 510(K)
- K870414QUIK-BRUSH1Cleared 510(K)
- K871359CHECK-MATE AND CHECK-MATE [+]1Cleared 510(K)
- K870906CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 45001Cleared 510(K)
- K864455THE EXPERIMENTAL1Cleared 510(K)
- K852691ODONTO TOOTHBRUSH1Cleared 510(K)
- K852400PLAK SMACKER1Cleared 510(K)
- K834580REACH* TOOTHBRUSH1Cleared 510(K)
- K833815ZACT DENTAL ARCH TOOTHBRUSCH1Cleared 510(K)
- K812361PORTABLE TOOTHBRUSH KIT (NO SAMPLE)1Cleared 510(K)
- K812362DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST1Cleared 510(K)
- K812363DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED1Cleared 510(K)
- K812364PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE1Cleared 510(K)
- K800831PY-CO-PROX TM DENTAL BRUSH1Cleared 510(K)
- K800154TOTE-BRUSH1Cleared 510(K)
- K781962DIJI-DENT1Cleared 510(K)
- K781018DX TOOTHBRUSH1Cleared 510(K)
- K771184TOOTHBRUSH, ORTHODONTIC, #0126-0189-001Cleared 510(K)
- K771185PERIODONTIC TOOTHBRUSH, #0126-0190-001Cleared 510(K)
- K771183TOOTHBRUSH, PEDODONTIC, #0126-0188-001Cleared 510(K)
- K770749TOOTHBRUSH, REACH1Cleared 510(K)
- K770464TOOTHBRUSH, PLAK-A-DENT1Cleared 510(K)
- K761352DENTAL STAIN REMOVER1Cleared 510(K)
- K760512TOOTHBRUSH1Cleared 510(K)
- 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
- 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
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- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
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- UnknownReview Panel
BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K950993
- 510(k) Type
- Traditional
- Applicant
- JOHN O. BUTLER
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/2/1995
- Days to Decision
- 91 days
- Submission Type
- Summary