Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- MiscellaneousMiscellaneous
- LTGPaste, Injectable For Vocal Cord Augmentation3Product Code
- LWMDevice, Electrical Dental AnesthesiaUProduct Code
- MCLKit, Test, In Vitro Periodontal3Product Code
- MQCMouthguard, PrescriptionUProduct Code
- MVLCord, RetractionUProduct Code
- KJJCleanser, Root CanalUProduct Code
- LFDSaliva, ArtificialUProduct Code
- LMWSolution, Removal, Carries3Product Code
- LPGMaterial, Dressing, Surgical, Polylactic Acid3Product Code
- LQYLocator, Root ApexUProduct Code
- NSJRestoration, Noble MetalNProduct Code
- NSKDentures, PartialNProduct Code
- NSLDentures, FullNProduct Code
- NSMRestoration, ResinNProduct Code
- NSNRestoration, Resin, Crown And BridgeNProduct Code
- NSORestoration, Porcelain-Fused-To-MetalNProduct Code
- NSPRestoration, PorcelainNProduct Code
- NSQRestoration, Base MetalNProduct Code
- NSRProsthesis, OrthodonticNProduct Code
- NXJDenture, Cosmetic OnlyNProduct Code
- OBRMouthguard, Over-The-CounterUProduct Code
- OCOMouthguard, Migraine/Tension HeadacheUProduct Code
- OLROral Wound DressingUProduct Code
- OLSOral Wound Dressing W/Drug And/Or BiologicUProduct Code
- PKJCrown And Bridge Material, Resin BasedNProduct Code
- QUAIntraoral Cooling Device2Product Code
- SBCDental Image Analyzer2Product Code
- Submissions with No Product CodeMiscellaneous
- K896826SULTAN PERIO-SELECT IRRIGATION SYSTEMCleared 510(K)
- K863834EVIDENT MARK 2 APEX LOCATORCleared 510(K)
- K863011DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-IICleared 510(K)
- K863012MINILAX SETCleared 510(K)
- K863014ISOPRAT F-III SET/ISOLAX CHAIRCleared 510(K)
- K863007EUROFLEX F-IV, ISOFLEX IIICleared 510(K)
- K863015ISOPRAT C-III SET/ISOCART III AUXILIARY UNITCleared 510(K)
- K863013ISOLAX PEDAL SETCleared 510(K)
- K863017ISOLAX (GNATUS)/ISOLAX PEDAL/MINILAXCleared 510(K)
- K863018DENTATUS-S / L / LS / (GNATUS)Cleared 510(K)
Show All 67 Submissions
- 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
- 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
EVIDENT MARK 2 APEX LOCATOR
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K863834
- 510(k) Type
- Traditional
- Applicant
- PULPDENT CORP. OF AMERICA
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/6/1987
- Days to Decision
- 129 days