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510(k) Data Aggregation
(143 days)
Soft Reline is a visible light cure soft reline material for removable dentures. It is intended for short-term use of at least 30 days.
Soft Reline is a visible light cure soft reline material for removable dentures.
The provided document is an FDA 510(k) clearance letter for a medical device called "Liner II: Soft Reline Liquid." This document does not describe any acceptance criteria or a study proving the device meets those criteria. Instead, it is a regulatory approval letter stating that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on performance criteria or a study demonstrating achievement of those criteria.
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(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.
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