(42 days)
Admira Flow is a light-curing and radiopaque filling material. Admira Flow is intended to be used for the following types of restorations in both anterior and posterior teeth:
- fillings with minimally invasive preparation technique .
- filling small cavities and sealing extended fissures .
- blocking out undercuts ◆
- lining or coating cavity walls .
- Class III-V filings, including V-shaped defects and cervical caries .
- repairing fillings and veneers .
- luting of translucent prosthetic pieces (e.g., porcelin-only-crowns)
Admira Flow is a flowable, light-curing, and radiopaque filling material based on ormocer composite technology. Admira Flow is suitable for restorations in both anterior and posterior teeth. Admira Flow is a low viscosity composite that offers excellent wetting and adhesion. Patent-protected ormocer chemistry provides excellent strength, abrasion resistance, and adhesion to the tooth structure, while making Admira Flow easy and fast to use. Admira Flow contains 64% (by volume. 54% by weight) inorqanic micro-particles (0.7 um) and fumed silica (0.05 um). Admira Flow cures under halogen light (blue light) and can be polished to a high gloss that is durable and color stable.
Admira Flow is available both as 1.8gm syringes and as single-use Admira Flow Caps (0.25gm) for direct intra-oral application. Admira Flow is available in six shades (A1, A2, A3, A3.5. A4, OA3.5).
The provided document is a 510(k) Summary for the dental restorative material ADMIRA FLOW®, submitted by VOCO GmbH. It focuses on demonstrating substantial equivalence to a predicate device and outlines the material's properties and intended use. However, it does not contain any information about acceptance criteria, performance studies with specific metrics, sample sizes for test or training sets, expert qualifications, or adjudication methods. It primarily summarizes the device description, intended use, and a technological comparison to a predicate device.
Therefore, I cannot provide the requested information from the given text. The document does not include the details of clinical performance studies that would typically define acceptance criteria and prove a device meets them. It only states that "The chemistry of Admira Flow raises no new issues or questions that effect safety, effectiveness, or biocompatibility for dental composite product."This suggests that safety and effectiveness are established through the equivalence to the predicate device and the common chemical components, rather than new performance studies with specific metrics outlined here.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.