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510(k) Data Aggregation
(115 days)
The resin discs TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON are polymethylmethacrylate and polycarbonate discs indicated to manufacture temporary anterior and posterior crowns and bridges, with up to two adjacent pontics, that can be kept in the mouth for up to 12 months.
TEMP BASIC are PMMA discs intended for the fabrication of temporary anterior crowns and bridges, with up to one adjacent pontic, with a maximum recommended usage time of 12 months.
TRY-IN, BURNOUT and TRY-IN & BURNOUT are PMMA discs intended for the fabrication of temporary crowns and bridges that can be kept in the mouth for up to 24 hours as for TRY-IN, and up to 60 minutes as for BURNOUT and TRY-IN &BURNOUT.
Intended use: polymer blanks used in dental CAD/CAM milling systems by professional dental technicians to manufacture dental crowns and bridges
The subject devices are composed of polymethylmethacrylate (PMMA) or polycarbonates (PC) and pigments. They are available in different models that differ in basic material, form and color. The materials used for the submitted devices have a long history of safe use for same or equivalent indications.
The blanks are available in different forms (the diameter of the block can be 95 mm or 98 mm, with step or without step) and heights (from 8 to 30mm) for different milling systems.
The usage period of the subject devices is limited: TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE and THERAPON discs can be kept in the oral cavity for up to 12 months; TRY-IN can be kept in the oral cavity for up to 24 hours, while BURNOUT and TRY-IN & BURNOUT devices can remain in the mouth for a maximum of 60 minutes.
The provided text describes a 510(k) premarket notification for dental polymer blanks. This type of document is for demonstrating substantial equivalence to a predicate device, not for describing the acceptance criteria and study proving a device meets them for a novel AI/software product. Therefore, much of the requested information regarding AI/software performance studies is not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria and the performance relative to a standard for the physical properties of these dental devices.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the subject devices are based on their compliance with the International Standard ISO 10477:2004 for polymer-based dental restorative materials. The reported device performance is presented as the measured values for flexural strength, water absorption, and water solubility.
| Property | Acceptance Criteria (based on ISO 10477:2004) | Reported Device Performance (Subject Devices) | Reported Device Performance (Predicate Device: IDODENTINE) | Comparison |
|---|---|---|---|---|
| Flexural Strength | Must correspond with the requirements of the standard (specific numerical requirement not explicitly stated but implied by "Similar" comparison to predicate). | TEMP BASIC: 64 MPa | ||
| TEMP PREMIUM: 106 MPa | ||||
| TEMP PREMIUM FLEXIBLE: 110 MPa | ||||
| MULTISTRATUM FLEXIBLE: 120 MPa | ||||
| THERAPON: 115 MPa | ||||
| TRY-IN: 65.32 MPa | ||||
| BURNOUT: 53.66 MPa | ||||
| TRY-IN & BURNOUT: 57.34 MPa | IDODENTINE MULTILAYER: 83 MPa | |||
| IDODENTINE TRANSPA: 94 MPa | Similar. The Temp Basic, Try-In, Burnout, and Try-In & Burnout have lower values, but these differences are deemed "not significant" due to their limited usage. | |||
| Water Absorption | Must correspond with the requirements of the standard. | TEMP BASIC: 20.46 µg/mm³ | ||
| TEMP PREMIUM: 19.36 µg/mm³ | ||||
| TEMP PREMIUM FLEXIBLE: 3.97 µg/mm³ | ||||
| MULTISTRATUM FLEXIBLE: 2.90 µg/mm³ | ||||
| THERAPON: 14.1 µg/mm³ | ||||
| TRY-IN: 20.47 µg/mm³ | ||||
| BURNOUT: 20.10 µg/mm³ | ||||
| TRY-IN & BURNOUT: 19.68 µg/mm³ | IDODENTINE MULTILAYER: 22.3 µg/mm³ | |||
| IDODENTINE TRASPA: 25.8 µg/mm³ | Similar | |||
| Water Solubility | Must correspond with the requirements of the standard. | TEMP BASIC: 0 µg/mm³ | ||
| TEMP PREMIUM: |
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