Search Results
Found 1 results
510(k) Data Aggregation
K Number
K980840Device Name
LOKKI DTManufacturer
Date Cleared
1999-03-15
(376 days)
Product Code
Regulation Number
878.4810Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Pulpotomy Filling material such as gutta percha or resin bakelite removal as adjunct treatment during root canal retreatment
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental laser (LOKKI DT Laser and Accessories). This document does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request to describe these elements based on the given text.
Ask a Question
Ask a specific question about this device
Page 1 of 1