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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
2023 1 1
2024 32 32
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 28 28
Patient Device Interaction Problem 4 4
Device Appears to Trigger Rejection 1 1
Structural Problem 1 1
Contamination /Decontamination Problem 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 18 18
Deformity/ Disfigurement 8 8
Hypersensitivity/Allergic reaction 5 5
Laceration(s) 2 2
Tissue Breakdown 1 1
Muscular Rigidity 1 1
Pain 1 1
Loss of Range of Motion 1 1
Unspecified Infection 1 1
Swelling/ Edema 1 1
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Feb-10-2025
2 Cardinal Health 200, LLC II Jan-15-2025
3 Centurion Medical Products Corporation II Feb-05-2020
4 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
5 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
6 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
14 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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