(52 days)
LC Pit & Fissure Sealant is a clear, light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth, and restorations to help protect against caries.
LC Pit & Fissure Sealant is a clear, light-activated dental sealant.
This document is a 510(k) clearance letter for a dental sealant. It does not contain information regarding acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria.
The information provided in the letter is limited to:
- Device Name: LC Pit & Fissure Sealant
- Regulatory Class: II
- Product Code: EBC
- Intended Use/Indications for Use: "LC Pit & Fissure Sealant is a clear, light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth, and restorations to help protect against caries."
- Date of Submission and Clearance.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study to prove their fulfillment based on the provided document. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, not on specific performance metrics or clinical study results.
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.