Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- EASGel, Electrode, For Pulp Tester1Product Code
- EATTester, Pulp2Product Code
- 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
- K242103TRIOS Ready Tip2Cleared 510(K)
- K221275Qraycam PRO2Cleared 510(K)
- K231722SmarTooth2Cleared 510(K)
- K223470C502Cleared 510(K)
- K221249L1P-1F (TRIOS 5)2Cleared 510(K)
- K183471IC-WHCD100 (Inspire)2Cleared 510(K)
- K171007Fluorescence Mode2Cleared 510(K)
- K170822Electronic Caries Detector2Cleared 510(K)
- K150672VistaCam iX Proof2Cleared 510(K)
- K121685SOPROCARE2Cleared 510(K)
- K112139THE CANARY SYSTEM2Cleared 510(K)
- K111423CS 1600 INTRAORAL CAMERA2Cleared 510(K)
- K111321REMOTE VIEW SOFTWARE2Cleared 510(K)
- K093705FUORECAM2Cleared 510(K)
- K092583SOPROLIFE2Cleared 510(K)
- K090598CARIESCAN PRO2Cleared 510(K)
- K090169SPECTRA FLUORESCENCE CARIES DETECTION DEVICE2Cleared 510(K)
- K063321D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N1382Cleared 510(K)
- K051909DIAGNODENT2Cleared 510(K)
- K042394DIAGNODENT PERIO TIP (ACCESSORY)2Cleared 510(K)
- K043156D-CARIE, MODEL N121-M12Cleared 510(K)
- K040063INSPEKTOR PRO2Cleared 510(K)
- DEN990002KAVO DIAGNODENT2Cleared 510(K)
- 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
- 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
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- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138
- Page Type
- Cleared 510(K)
- 510(k) Number
- K063321
- 510(k) Type
- Traditional
- Applicant
- NEKS TECHNOLOGIES, INC.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/30/2007
- Days to Decision
- 148 days
- Submission Type
- Summary