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
- 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
- K091964CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS1Cleared 510(K)
- K964976FLOSSBRUSH WITH FLUORIDE1Cleared 510(K)
- K963746IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID1Cleared 510(K)
- K944034PERIO-MED DENTAL FLOSS1Cleared 510(K)
- K952091VUTLER G.U.M. WITH FLUORIDE1Cleared 510(K)
- K951917JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS1Cleared 510(K)
- K944886COLGATE PRECISION MINT WZXED DENTAL FLOSS1Cleared 510(K)
- K943157ORAL-B ULTRAFLOSS WITH FLLUORIDE1Cleared 510(K)
- K942689RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE1Cleared 510(K)
- K942690RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE1Cleared 510(K)
- K935440JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED1Cleared 510(K)
- K935522RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE1Cleared 510(K)
- K931353FLOSS PLUS1Cleared 510(K)
- K925409ORAL-B DENTAL FLOSS WITH FLUORIDE1Cleared 510(K)
- K925408ORAL-B DENTAL TAPE WITH FLUORIDE1Cleared 510(K)
- K921601ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE1Cleared 510(K)
- K914962FUN FLOSS1Cleared 510(K)
- K913087DENTAL FLOSS1Cleared 510(K)
- K912430DENTAL FLOSS1Cleared 510(K)
- K911701G-FLOSS & G-FLOSS II1Cleared 510(K)
- K911470BUFFING FLOSS1Cleared 510(K)
- K905382SCRIBBON1Cleared 510(K)
- K902325DENTAL CLEANING RINGS1Cleared 510(K)
- K903712FLOSSIE TOOTHFLOSS1Cleared 510(K)
- K885056TWIXEL(TM)1Cleared 510(K)
- K884145FLOSER PLUS1Cleared 510(K)
- K882571KOLYNOS DENTAL FLOSS1Cleared 510(K)
- K883335COLGATE DENTAL FLOSS1Cleared 510(K)
- K883024ORAL-B FLOSSERS1Cleared 510(K)
- K882828DENTAL FLOSS PICK1Cleared 510(K)
- K882164FLOSS CARD1Cleared 510(K)
- K874471SUPER FLOSSER1Cleared 510(K)
- K871736CARERITE BIOPACK GINGIVAL RETRACTION CORD1Cleared 510(K)
- K871393DR FLOSSER, FLOSSING AID/FLOSS HOLDING DEVICE1Cleared 510(K)
- K871392DR FLOSSER REFILL1Cleared 510(K)
- K870996SEWON DENTAL FLOSSER1Cleared 510(K)
- K864832DENTAL FLOSS1Cleared 510(K)
- K862694FLOSS CARD1Cleared 510(K)
- K860963'E-Z FLOSS' AND 'LAZY FLOSS'1Cleared 510(K)
- K860769DENTAL FLOSS HOLDER1Cleared 510(K)
- K860324DENTAL FLOSS CARD1Cleared 510(K)
- K855113FLOSS HOLDER (PLASTIC)1Cleared 510(K)
- K854701RETRACT-A-CORD1Cleared 510(K)
- K853767FLOSPIK1Cleared 510(K)
- K844626MINI FLOW- DENTAL FLOSS1Cleared 510(K)
- K844438SIMPLIFLOS DENTAL FLOSSER1Cleared 510(K)
- K842846SEWON DENTAL FLOSS FOLDER1Cleared 510(K)
- K841675FLOSS N' GLOSS/SAFETY FLOSS MED DEVICE1Cleared 510(K)
- K840093DENTAL FLOSSING INSTRUMENT1Cleared 510(K)
- K831254DENTAL FLOSS HOLDER1Cleared 510(K)
- K830225THE TOOTHPIK1Cleared 510(K)
- K823278DENTAL FLOSS TIP1Cleared 510(K)
- K821685TOM'S NATURALLY WAXED FLOSSING TAPE1Cleared 510(K)
- K821155DENTAL FLOSS HOLDER1Cleared 510(K)
- K813248DENTAL FLOSS HOLDER1Cleared 510(K)
- K812120GINGI-PLAIN CORDS & BRAIDS1Cleared 510(K)
- K811926SE WON(ALUMINUM) DENTAL FLOSS HOLDER1Cleared 510(K)
- K811555DENTAL FLOSS HOLDER1Cleared 510(K)
- K803129GO-BETWEEN1Cleared 510(K)
- K792493GENTLE FLOSS1Cleared 510(K)
- K791223DEN-MAT DENTAL FLOSSER1Cleared 510(K)
- K760571FLOSS-A-LOT1Cleared 510(K)
- 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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- NeurologyReview Panel
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- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
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- UnknownReview Panel
SEWON DENTAL FLOSS FOLDER
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K842846
- 510(k) Type
- Traditional
- Applicant
- SEWON INDUSTRY
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/17/1984
- Days to Decision
- 28 days