Search Results
Found 1 results
510(k) Data Aggregation
Device Name
Dental Cone; Dental SpongeManufacturer
Date Cleared
2025-12-18
(23 days)
Product Code
Regulation Number
N/AType
SpecialPanel
DentalAge Range
All
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Indicated for the management of oral wounds and sores, including: denture sores, oral ulcers (non-infected or viral), periodontal surgical wounds, suture sites, burns, surgical wounds and traumatic wounds.
Device Description
Dental Cone and Sponge are collagen matrices, conformable and resorbable, manufactured from purified type I collagen derived from bovine Achilles tendon. Dental Cone and Sponge are supplied sterile, non-pyrogenic, and for single use only.
AI/ML Overview
N/A
Ask a Question
Ask a specific question about this device
Page 1 of 1