Search Results
Found 2 results
510(k) Data Aggregation
K Number
K000878Device Name
HONIGUMManufacturer
Date Cleared
2000-04-11
(22 days)
Product Code
Regulation Number
872.3660Type
AbbreviatedPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
K Number
K980963Device Name
HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)Manufacturer
Date Cleared
1998-05-11
(56 days)
Product Code
Regulation Number
872.3660Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Honigum® Automix and Honigum® Quick are polysiloxane impression materials to be applied by the dental professional prior to fabrication of crowns, bridges and inlays for their patients.
Device Description
polysiloxane impression materials
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for a dental impression material. It does not describe any acceptance criteria or a study proving that a device meets such criteria. It's a regulatory approval document confirming substantial equivalence to a predicate device, not a technical performance report.
Therefore, I cannot extract the requested information from this document.
Ask a Question
Ask a specific question about this device
Page 1 of 1