Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- EASGel, Electrode, For Pulp Tester1Product Code
- EATTester, Pulp2Product Code
- K022097THERMIQUE2Cleared 510(K)
- K021298ELEMENTS DIAGNOSTIC UNIT2Cleared 510(K)
- K012427PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT2Cleared 510(K)
- K011666CHILLIT2Cleared 510(K)
- K990225ENDO ANALYZER, MODEL 8005, MODIFIED2Cleared 510(K)
- K973439ENDO ANALYZER, MODEL 80052Cleared 510(K)
- K970715SYSTEM B HEAT SOURCE2Cleared 510(K)
- K963862TOUCH N' HEAT2Cleared 510(K)
- K960799ORTHO-ICE2Cleared 510(K)
- K950237DIGITEST2Cleared 510(K)
Show All 22 Submissions
- EGZHolder, Film, X-Ray1Product Code
- EHAAligner, Beam, X-Ray1Product Code
- JEOMeasurer, Gingival Fluid1Product Code
- LFCDevice, Caries Detection2Product Code
- MVHDevice, Detection, Sulfide2Product Code
- NBLLaser, Fluorescence Caries Detection2Product Code
- NFPDevice, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders2Product Code
- NFQDevice, Dental Sonography, For Monitoring Jaw Sounds1Product Code
- NFRDevice, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders2Product Code
- NFSDevice, Jaw Tracking, For Monitoring Jaw Positions1Product Code
- NTKCaries Detector, Laser Light, Transmission2Product Code
- NYHPlaque Disclosing Kit2Product Code
- 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
- Ear, Nose, ThroatReview Panel
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- 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
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- UnknownReview Panel
PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K012427
- 510(k) Type
- Traditional
- Applicant
- Specialites Septodont
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/9/2001
- Days to Decision
- 70 days
- Submission Type
- Statement