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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device general purpose dental tray
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. 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.
Product CodeOFX
Regulation Number 872.6640
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Component Missing 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
4 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
5 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
6 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022