(214 days)
LANG DENTAL Jet XR Radiopaque Acrylic Resin is intended for the fabrication of methacrylate-based acrylic appliances and used wherever a radiopague acrylic dental device is useful in establishing an anatomical location or site, such as a provisional implant stent
Lang Dental Jet XR Radiopaque Acrylic Resin is a high quality self curing 2-part system. The system is formed by a powder polymer and liquid monomer. The combination of powder polymer and liquid monomer is converted into a hard methacrylate finished product. Lang Dental Jet XR Radiopaque Acrylic Resin is intended for the fabrication of methacrylate-based actylic appliances that require radiopacity.
The provided text describes a 510(k) submission for the "Lang Dental Jet XR Radiopaque Acrylic Resin" and does not contain information about acceptance criteria or a study proving that a device meets those criteria.
Instead, the document focuses on:
- Device Identification: Trade Name (Jet XR), Common Name (Radiopaque Acrylic Resin), Classification Name (Dental Product), Product Code (EBI).
- Intended Use: Fabrication of methacrylate-based acrylic appliances and use where a radiopaque acrylic dental device is useful in establishing anatomical location or site (e.g., provisional implant stent).
- Technological Characteristics: It's a methyl methacrylate resin compound, identical to the predicate (OrthoJet Acrylic Resin) except for the addition of Barium Sulfate for radiopacity.
- Performance Data:
- Non-Clinical Data: Physical property tests (flexural strength, modulus, sorption, and solubility) were conducted. The conclusion was that performance characteristics "appeared adequate" because the product is not under stress in its intended diagnostic applications, and no ISO or ADA standards exist for provisional restorative or diagnostic products.
- Clinical Data: None was submitted, as the chemical composition was nearly identical to the predicate, with Barium Sulfate having established biocompatibility.
- Conclusion of Substantial Equivalence (SE): The product was deemed substantially equivalent to the predicate because it's for diagnostic purposes, and its chemical composition is essentially the same as the predicate, with the addition of biocompatible radiopaque Barium Sulfate.
Therefore, I cannot fulfill your request for the tables and details of a study proving acceptance criteria, as this information is explicitly stated as not present in the provided 510(k) summary. The submission relied on the substantial equivalence to a predicate device and existing knowledge of the added component's biocompatibility, rather than a new clinical performance study.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.