Oral Surgery Tray

FDA product code PWL · Class I (low risk) · 21 CFR 872.4565 · Dental

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

0510(k) clearances
0PMA approvals
15recalls

Recalls

RecallProductFirmInitiated
Z-0511-2023 Class IIHENRY SCHEIN, ENT PACK, Item No.570-2718Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0497-2023 Class IISurgical room, DENTAL SURGICAL PACK, Item No.41236SDSPMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0496-2023 Class IISTRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dentalMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0495-2023 Class IISTRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0492-2023 Class IISurgical room, SURGICAL PACK, Item No.40996WLS, oral surgery trayMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0491-2023 Class IISTRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery trayMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0490-2023 Class IISTRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery trayMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0489-2023 Class IISTRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dentalMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0488-2023 Class IISTRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery trayMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0487-2023 Class IISTRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery trayMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0486-2023 Class IISTRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery trayMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0485-2023 Class IISTRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dentalMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0484-2023 Class IIBASIC IMPLANT PACK, Item No. 40310SBI, oral surgery trayMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0483-2023 Class IISTRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSSMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified
Z-0482-2023 Class IIACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery trayMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in… Stradis Medical, LLC dba Stradis Healthcare11/02/2022Open, Classified