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
- K251425turbodent touch2Cleared 510(K)
- K063236BETA-POWDER2Cleared 510(K)
- K042872RONDOFLEX PLUS 3602Cleared 510(K)
- K033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER2Cleared 510(K)
- K033215PREPAIR2Cleared 510(K)
- K024105VELOPEX AQUACUT FLUID ABRASION UNIT2Cleared 510(K)
- K030292GROMAN PREPMASTER2Cleared 510(K)
- K021450CLINPRO PROPHY POWDER2Cleared 510(K)
- K014188NEW PROPHY POWDER2Cleared 510(K)
- K014249JETPOLISHER2Cleared 510(K)
- K014249JETPOLISHER2Cleared 510(K)
- K014245JETSONIC 20002Cleared 510(K)
- K013969MINIBLASTER2Cleared 510(K)
- K993182DISPOPROPHY2Cleared 510(K)
- K993124DISPODRILL2Cleared 510(K)
- K984380DISPO ETCH2Cleared 510(K)
- K010816DENTO-PREP PARTICLE MICROBLASTER2Cleared 510(K)
- K002708KAVO CORUND HANDPIECE 20132Cleared 510(K)
- K990060MACH 72Cleared 510(K)
- K001313AIRDENT II CS2Cleared 510(K)
- K980672SIMPLEX AIRBRATOR (SAB-7)2Cleared 510(K)
- K984415S.S. WHITE TECHNOLOGIES, MODELS 6500-D,6500-E, AND 6500-F2Cleared 510(K)
- K990545JETSONIC 20002Cleared 510(K)
- K981564AIR TECHNIQUES' AIRDENT II2Cleared 510(K)
- K974655PREPTECH(TM) 200 CAVITY PREPARATION SYSTEM2Cleared 510(K)
- K980216KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 62Cleared 510(K)
- K974488AIRPREP SYSTEM - MODEL 90012Cleared 510(K)
- K980726ULTRA-BLASTER2Cleared 510(K)
- K973679AEROETCHER2Cleared 510(K)
- K970589MICROETCHER AP2Cleared 510(K)
- K964755MICROJET CAVITY PREPARATION SYSTEM2Cleared 510(K)
- K970484ACCU-PREP2Cleared 510(K)
- K970249SIMPLEX AIRBRATOR2Cleared 510(K)
- K964145ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-12Cleared 510(K)
- K964059MICADENT2Cleared 510(K)
- K955573OPTIBLAST INTRAORAL SANDBLASTER2Cleared 510(K)
- K955050JETSTREAM CAVITY PREPARATION SYSTEM2Cleared 510(K)
- K931845SANDBLASTER2Cleared 510(K)
- K940776KREATIV MODEL KV-12Cleared 510(K)
- K932997MICROPREP CAVITY PREPERATION SYSTEM2Cleared 510(K)
- K921748MODEL 2000 DENTAL AIR ABRASIVE SYSTEM2Cleared 510(K)
- K903284YOUNG PROPHY SYSTEM, PS UNIT2Cleared 510(K)
- K902836MICROETCHER2Cleared 510(K)
- K875340JETPOLISHER(TM)2Cleared 510(K)
- K871980D-23 DENTURE ADHESIVE2Cleared 510(K)
- K862384SCHEIN AP-1 AIR POLISHING UNIT2Cleared 510(K)
- K852521SATLEC PROPHY UNIT PU 30552Cleared 510(K)
- K840720FIBER HEMOFILTERS FH55-FH77 & 882Cleared 510(K)
- 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
KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K980216
- 510(k) Type
- Traditional
- Applicant
- Kreativ, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/16/1998
- Days to Decision
- 146 days
- Submission Type
- Summary