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
- K171189AIR-FLOW PLUS Prophylaxis powder1Cleared 510(K)
- K131760WHIP MIX PREPPIES PLUS1Cleared 510(K)
- K121698NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN1Cleared 510(K)
- K103114OSSPRAY SYLC CR1Cleared 510(K)
- K102053BUTLER CALCI-FLOR PROPHYLAXIS PASTE1Cleared 510(K)
- K101104REMIN PRO1Cleared 510(K)
- K100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE1Cleared 510(K)
- K070854GC MI PASTE PLUS1Cleared 510(K)
- K062502OSSPRAY CLEANING COMPOUND1Cleared 510(K)
- K062166ENAMEL PRO1Cleared 510(K)
- K042048GELATO PROPHYLAXIS PASTE1Cleared 510(K)
- K042200MI PASTE1Cleared 510(K)
- K041371BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN1Cleared 510(K)
- K040988ZIRCON-F PROPHYLAXIS PASTE1Cleared 510(K)
- K033785PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE1Cleared 510(K)
- K040661RADENT PROPHY PASTE1Cleared 510(K)
- K033449PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES1Cleared 510(K)
- K024343BUTLER GUM PROPHY PASTE WITH NOVAMIN1Cleared 510(K)
- K002989PROCLUDE1Cleared 510(K)
- K000169NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN1Cleared 510(K)
- K9904823M CLINPRO PROPHY PASTE, MODEL 126111Cleared 510(K)
- K973289RE NU1Cleared 510(K)
- K983966NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN1Cleared 510(K)
- K962370PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE1Cleared 510(K)
- K944575AQUAFRESH PLAQUE FIGHTING GUM1Cleared 510(K)
- K942851SMILE INTEGRATED PROPHYLAXIS PASTE RINGS1Cleared 510(K)
- K940496PROPHY PASTE1Cleared 510(K)
- K935925VISION PROPHY PASTE WITH FLUORIDE1Cleared 510(K)
- K933893VISION PROPHY PASTE WITHOUT FLUORIDE1Cleared 510(K)
- K923674DENSPRO COARSE MINT PROPHY PASTE1Cleared 510(K)
- K923675DENSPRO MEDIUM MINT PROPHY PASTE1Cleared 510(K)
- K923020CLEANIC1Cleared 510(K)
- K912945SATIN PROPHYLAXIS PASTE1Cleared 510(K)
- K905303ABUTMENT GLO1Cleared 510(K)
- K911284PULPDENT DIAMOND POLISH1Cleared 510(K)
- K903986SWIRL PROPHYLAXIS PASTE1Cleared 510(K)
- K904199HORIZON REGULAR ETCHING GEL1Cleared 510(K)
- K901580PROPHY PASTE1Cleared 510(K)
- K903003MPS DIAMOND POLISHING GEL1Cleared 510(K)
- K896071ULTRA II PORCELAIN POLISHING PASTE1Cleared 510(K)
- K901873DEGUFILL (R) POLISHING GEL1Cleared 510(K)
- K901973CP-3 DENTAL POLISHING MATERIAL1Cleared 510(K)
- K901052PULPDENT OIL FREE SURFACE PREPARATION PASTE1Cleared 510(K)
- K896661KEN'S PROPHY GEL - REGULAR1Cleared 510(K)
- K894933PERLIDENT1Cleared 510(K)
- K891536ENAMEL MICROABRASION COMPOUND1Cleared 510(K)
- K875339JETPOLISHER AIRPOLISHING POWDER1Cleared 510(K)
- K873686DIAMOND-LUSTER DENTAL POLISHING PASTE1Cleared 510(K)
- K872251ABRASIVE DISC - POLISHING WHEEL1Cleared 510(K)
- K864226JOHNSON & JOHNSON STAINING REMOVING COMPOUND1Cleared 510(K)
- K865082PROPHY CARE SOLUTION1Cleared 510(K)
- K864215PROPHY CARE SOLUTION1Cleared 510(K)
- K863133PROPHY CARE PASTE1Cleared 510(K)
- K862912RENAMELIZE POLISHING PASTE1Cleared 510(K)
- K860843CHECK-UP PLAQUE FIGHTING GUM1Cleared 510(K)
- K854828SCI-PRO, PROPHYLAXIS PASTE1Cleared 510(K)
- K854829DENSCO PROPHY PASTE1Cleared 510(K)
- K854588INSTA-GLAZE1Cleared 510(K)
- K852814GLOSSY POLISHING PASTE1Cleared 510(K)
- K851073CUPRIDENT1Cleared 510(K)
- K852157TEMREX DENTAL POLISHING PASTE1Cleared 510(K)
- K852489PROPOL DENTAL POLISHING PASTE1Cleared 510(K)
- K843022KERR COMMAND ULTRAFINE POLISHING PASTE1Cleared 510(K)
- K842403LUSTER, DENTAL POLISHING PASTE1Cleared 510(K)
- K840254DIAMOND LUSTRE1Cleared 510(K)
- K822894DIABRITE1Cleared 510(K)
- K822142DIAGLAZE1Cleared 510(K)
- K812118NIMETIC POLISHING PASTE1Cleared 510(K)
- K810912ALLOY COMPOSITE POLISH1Cleared 510(K)
- K810037DENTAL CHEWING GUM (SUGARLESS)1Cleared 510(K)
- K801225DEN-MAT POLISHING PASTE1Cleared 510(K)
- K791319MIRADAPT* POLISHING INSTRUMENTS1Cleared 510(K)
- K780834PREVI DENT PROPHYLAXIS MINT NDC1Cleared 510(K)
- K771852NIMETIC POLISHING PASTE1Cleared 510(K)
- K771401PROPHY PASTE1Cleared 510(K)
- K760658DETARTRINE P1Cleared 510(K)
- K760656DETARTRINE Z1Cleared 510(K)
- 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
- 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
MI PASTE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K042200
- 510(k) Type
- Traditional
- Applicant
- GC AMERICA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/20/2004
- Days to Decision
- 68 days
- Submission Type
- Statement