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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
Regulation Description Dental operative unit and accessories.
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

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
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