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510(k) Data Aggregation
K Number
K061337Device Name
WIEDENT ESTETICManufacturer
Date Cleared
2006-06-07
(26 days)
Product Code
Regulation Number
872.3590Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
WIEDENT ESTETIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Acrylic teeth to be used for construction of full and partial dentures by a dental professional. Dentures are removable, not implanted in patients' mouths.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA for a device called "Wiedent Esthetic Teeth."
This type of letter primarily focuses on:
- Substantial Equivalence: It states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety and effectiveness.
- Regulatory Classification: It clarifies the device's regulatory class and product code.
- Compliance Requirements: It reminds the manufacturer of their ongoing responsibilities under the Federal Food, Drug, and Cosmetic Act.
The document does not include:
- Specific acceptance criteria for the device's performance (e.g., tensile strength, wear resistance, color stability).
- Details of any performance studies conducted to meet such criteria.
- Information on sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies.
Therefore, I cannot populate the table or provide the requested study details from the text you provided.
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