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510(k) Data Aggregation
K Number
K243910Device Name
RetraxilManufacturer
Date Cleared
2025-09-24
(279 days)
Product Code
Regulation Number
N/AType
TraditionalPanel
DentalPredicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
For the temporary displacement of the marginal gingiva and drying of the gingival sulcus, e.g. for
- conventional or digital impressions,
- cementation of temporary and permanent restorations
- and the creation of Class II and V fillings.
Device Description
RetraXil belongs to the group of dental retraction material, mainly as cords (threads) with astringent agents. The retraction material is also marketed in form of a paste as alternative to the cords. RetraXil is a retraction paste containing aluminium chloride as astringent agent, which serves as hemostatic agent.
RetraXil is marketed as a gingival retraction paste with no hints of performance or safety issues for patients and users.
Retraxil is a retraction paste stored in a 1g syringe with a cannula and twisting aid.
AI/ML Overview
N/A
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