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
- K023232SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE1Cleared 510(K)
- K001493DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 00200011Cleared 510(K)
- K983374AGATHA-A-H20101Cleared 510(K)
- K964810DERMADAM1Cleared 510(K)
- K952234BARRIER ALL FILM1Cleared 510(K)
- K943182ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR1Cleared 510(K)
- K923711PERIOFLEX TIP1Cleared 510(K)
- K923937HYDRO FLOSS1Cleared 510(K)
- K931380WATER PIK PLUS PLAQUE CONTROL SYSTEM1Cleared 510(K)
- K923457SHOWERFLOSS1Cleared 510(K)
- K922307SHOWERFLOSS ORAL IRRIGATION UNIT1Cleared 510(K)
- K921999INTERJET(TM) GINGIVAL CARE INSTRUMENT1Cleared 510(K)
- K913030MAX-I-PROBE IRRIGATION SYSTEM1Cleared 510(K)
- K910832OXYFRESH OXYCARE 30001Cleared 510(K)
- K901955PERIOGARD(R) PERIOPEN1Cleared 510(K)
- K905188PERIO PIK1Cleared 510(K)
- K904850DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 295551Cleared 510(K)
- K897053L'LL SQUIRT GUM ORAL RINSE DEVICE1Cleared 510(K)
- K901600OSSEOTITE IRRIGATION UNIT1Cleared 510(K)
- K900547WATER PIK(R) W/ADD'L CLAIMS1Cleared 510(K)
- K900178ELECTRIC MOTOR W/PHYSIO DISPENSER, HANDPIECES1Cleared 510(K)
- K900991SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET1Cleared 510(K)
- K896890DYNASURG DENTAL IRRIGATION SYSTEM1Cleared 510(K)
- K895259PIK POCKET(R), MODEL PP-31Cleared 510(K)
- K894015WATER PIK(R)1Cleared 510(K)
- K890600HYDRODENT ANTIPLAQUE SYSTEM1Cleared 510(K)
- K884220AIR WATER SYRINGE TIP SHIELD1Cleared 510(K)
- K882759PROFESSIONAL MODEL 7525 DELIVERY SYSTEM1Cleared 510(K)
- K875150PERIODONTAL SCALING SOLUTION-C1Cleared 510(K)
- K875149PERIDONTAL SCALING SOLUTION-B1Cleared 510(K)
- K875132PERIODONTAL SCALING SOLUTION-A1Cleared 510(K)
- K864540PLAK VAK - PV-101Cleared 510(K)
- K863131PIK POCKET (IRRIGATING TIP)1Cleared 510(K)
- K852593SUNBEAM DENTAL CARE CENTER, MODEL NO. 62731Cleared 510(K)
- K844339BRAUN DENTAL CENTER OC-31Cleared 510(K)
- K844318ORAL IRRIGATION TIP1Cleared 510(K)
- K840721PERIO PIK1Cleared 510(K)
- K834545POCKETIP 44141Cleared 510(K)
- K832222PRO PULSE PERIODONTAL IRRIGATOR 76181Cleared 510(K)
- K832223PERIODONTAL IRRIGATOR #76201Cleared 510(K)
- K831321GUM MACHINE1Cleared 510(K)
- K823305DENTO SPRAY ORAL IRRIGATOR1Cleared 510(K)
- K813638MULTI-UNIT, MULTI-PURPOSE DEVICE1Cleared 510(K)
- K811175RECOH ROOT CANAL IRRIGATOR1Cleared 510(K)
- K810864WATER PIK ORAL HYGIENE CENTER1Cleared 510(K)
- K802595ERGO IRRIGATION SYSTEM1Cleared 510(K)
- K800448WATER PIK TRAVELER, MODEL 791Cleared 510(K)
- 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
- 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
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- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
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- 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
GUM MACHINE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K831321
- 510(k) Type
- Traditional
- Applicant
- THE GUM MACHINE CO.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/7/1983
- Days to Decision
- 76 days