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
- 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
- K992270MIRACLEBREATH TONGUE CLEANER1Cleared 510(K)
- K990344ORALGIENE TONGUE CLEANER1Cleared 510(K)
- K983683UNIK TONGUE CLEANER1Cleared 510(K)
- K983087BREATHTIQUE TONGUE SCRAPER1Cleared 510(K)
- K981808BREATHAID TONGUE SCRAPER1Cleared 510(K)
- K980842COPPER TONGUE SCRAPER1Cleared 510(K)
- K980075CYBERSONIC1Cleared 510(K)
- K973424ENFRESH TONGUE BRUSH1Cleared 510(K)
- K973175TONGUE KLEAN1Cleared 510(K)
- K972644BREATH-SO-FRESH TONGUE CLEANER1Cleared 510(K)
- K972131BREATH ACE BREATHFRESHENER1Cleared 510(K)
- K971887BREATH TAKER1Cleared 510(K)
- K971025AYURVEDIC TONGUE CLEANER1Cleared 510(K)
- K970042OOLI-U(TONGUE SCRAPER)1Cleared 510(K)
- K962941OOLITT TONGUE CLEANER, REGULAR LOW RIPPLE/SPECIAL HIGH RIPPLE/LOW RIPPLE DOUBLE/HIGH & LOW RIPPLE/COMFORT EZE1Cleared 510(K)
- K961574TONGUE SCRAPPER1Cleared 510(K)
- K961660TONGUE CLEANER1Cleared 510(K)
- K952446TONGUE CLEAN1Cleared 510(K)
- K942076TONGUE SCRAPER1Cleared 510(K)
- K932839A MANO TONGUE CLEANSER1Cleared 510(K)
- K902164SYB, OR SAVE YOUR BREATH TONGUE CLEANER1Cleared 510(K)
- K901408THE TONGUE BRUSH1Cleared 510(K)
- K892388THE TONGUE CLEANER1Cleared 510(K)
- K870875COAT-A-COUNT PCP KIT NUMBER TKPC11Cleared 510(K)
- K851006T-SWIPE -TONGUE CLEANER1Cleared 510(K)
- K844291ARK TONGUE CLEANER1Cleared 510(K)
- K844292MEDI-TECH DILATATION CATHETERS1Cleared 510(K)
- K841077ARK TONGUE CLEANER1Cleared 510(K)
- K833838SILVERAK1Cleared 510(K)
- K810149TONGUE CLEANER1Cleared 510(K)
- K790895TONGUE SCRAPER1Cleared 510(K)
- 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
BREATH TAKER
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K971887
- 510(k) Type
- Traditional
- Applicant
- Hofa, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/10/1997
- Days to Decision
- 20 days
- Submission Type
- Statement