(113 days)
The Sealant (Infiltrant) is indicated for:
- Sealing of Pit and Fissures .
- Sealing/facing of damaged enamel surfaces .
- . Covering of caries predilection sites during orthodontic treatment
- Sealing of secondary teeth .
- Sealing of deciduous teeth .
The HCI Etching Gel is indicated for etching of enamel.
The purposed Infiltration Kit consists of two components, a light curing resin-based sealant (Infiltrant) combined with a 99.5% ethanol solution, which is used in a drying and conditioning step before the sealant application and as second component an HCI-Etching-Gel. The HCI-Etching-Gel is used as a preliminary step for etching of enamel. The proposed sealant (Infiltrant) is designed for use in sealing the enamel pits and fissures of teeth.
The provided text does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria.
The document discusses:
- A 510(k) summary for an "Infiltration Kit" (sealant and etching gel).
- Product description and indications for use.
- Predicate devices for comparison.
- A statement that the submission is an Abbreviated 510(k) as described in FDA's guidance document "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications."
- A conclusion stating the device is safe and effective based on indications for use, technological characteristics, and comparison to predicate devices.
- The FDA's decision letter determining substantial equivalence.
An Abbreviated 510(k) relies on conformance to recognized standards, special controls, or guidance documents rather than presenting new clinical study data to demonstrate safety and effectiveness. Therefore, the detailed information about study design, sample sizes, expert qualifications, and ground truth establishment that you've requested is typically not found in such a submission unless specifically required by a recognized standard or guidance document for a particular performance attribute.
Therefore, I cannot provide the requested information from the given text.
§ 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.