FDA 510(k) Applications for Medical Device Product Code "ELS"
(Splint, Endodontic Stabilizing)

FDA 510(k) Number Applicant Device Name Decision Date
K961704 DENTATUS USA, LTD. MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM 07/26/1996
K972985 JENERIC/PENTRON, INC. SPLINT IT 09/24/1997


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