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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
2023 1 1
2024 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 27 27
Patient Device Interaction Problem 4 4
Contamination /Decontamination Problem 1 1
Structural Problem 1 1
Sharp Edges 1 1
Device Appears to Trigger Rejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 18 18
Deformity/ Disfigurement 8 8
Hypersensitivity/Allergic reaction 4 4
Laceration(s) 2 2
Unspecified Infection 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Muscular Rigidity 1 1
Loss of Range of Motion 1 1
Pain 1 1
Swelling/ Edema 1 1
Tissue Breakdown 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Feb-05-2020
2 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
3 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
11 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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