Anesthesiology
Review Panel
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- 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
- K171254LeEject 2 Dental Syringe and Needle System2Cleared 510(K)
- K142414Miltex N-Tralig Intraligamentary Syringe2Cleared 510(K)
- K120659HU-FRIEDY DENTAL CARTRIDGE SYRINGE2Cleared 510(K)
- K113247ANESTHESIA INJECTION TOOL SET2Cleared 510(K)
- K082249MORPHEUS2Cleared 510(K)
- K092943ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE2Cleared 510(K)
- K083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT2Cleared 510(K)
- K081694DENJECTOR2Cleared 510(K)
- K061904COMPUDENT STA2Cleared 510(K)
- K043322MIRAMATIC SAFE SYRINGE SYSTEM2Cleared 510(K)
- K040671EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES2Cleared 510(K)
- K023722SAFETYWAND DISPOSABLE HANDPIECE2Cleared 510(K)
- K022959SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-12Cleared 510(K)
- K002168ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE2Cleared 510(K)
- K002387COMFORT CONTROL SYRINGE SYSTEM2Cleared 510(K)
- K992819WAND PLUS2Cleared 510(K)
- K991888MINIJECT2Cleared 510(K)
- K983105CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-012Cleared 510(K)
- K972285GETTIG STYRL-JECT DELIVERY SYSTEM2Cleared 510(K)
- K962999SAFETY INJECTION SYSTEM2Cleared 510(K)
- K961457SUBLIMINATOR2Cleared 510(K)
- K961648THE WAND2Cleared 510(K)
- K960270DENTALOGIC2Cleared 510(K)
- K945843SAFETY PLUS2Cleared 510(K)
- K950309EAGLE2Cleared 510(K)
- K941915ORAL STEEL CARTRIDGE SYRINGE2Cleared 510(K)
- K943370IMPULSE SEALER PRODUCT LINE2Cleared 510(K)
- K922683PRESTYL JET INJECTOR2Cleared 510(K)
- K926121BRASS NICK IMPRES TRAY/AMALGAM CAR/SYRIN CART/ARTI2Cleared 510(K)
- K913769SYREX SYRINGE2Cleared 510(K)
- K904527KAPPER2Cleared 510(K)
- K904278HOLDER, DENTAL BUR, ALUMINUM2Cleared 510(K)
- K903007MIRCAS DENTAL CARTRIDGE SYRINGE AND MIRCAS COVER2Cleared 510(K)
- K880621CAPCADDY2Cleared 510(K)
- K851903ASTRA LIGHTWEIGHT STAINLESS STEEL SELF ASPIR/SYRIN2Cleared 510(K)
- K843314MPL HYPO BRAND BREECH LOAD ASPIR SYRINGE2Cleared 510(K)
- K842006CITOJECT CARTRIDGE SYRINGE2Cleared 510(K)
- K833426DOCTOR VELLETTE'S INJECTOR2Cleared 510(K)
- K830524HENKE JECT PRESSURE SYRINGE2Cleared 510(K)
- K830042E-Z JECTOR2Cleared 510(K)
- K823536INTRALIG2Cleared 510(K)
- K821782BEACH ANESTHETIC SYRINGE CARTR. TYPE2Cleared 510(K)
- K811831MULTI-PURPOSE DENTAL SYRINGE2Cleared 510(K)
- K802483LIGMAJECT2Cleared 510(K)
- K792541MONOJECT PLASTIC DENTAL INJ. SYRINGE2Cleared 510(K)
- 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
- 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
SAFETY PLUS
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K945843
- 510(k) Type
- Traditional
- Applicant
- ARENT FOX
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/11/1995
- Days to Decision
- 223 days
- Submission Type
- Statement