The 510K-Certified PVS (Polyvinyl Siloxane) Dental Putty Kit is a premium impression material system designed for capturing the most accurate and detailed impressions in fixed prosthodontics, implantology, and complex restorative dentistry. Its regulatory clearance underscores its safety and performance for critical dental applications.
Technical Specifications & Material Science: This is an Addition-Cure Silicone material, meaning it cures via a platinum-catalyzed hydrosilylation reaction. This process produces zero by-products, resulting in exceptional dimensional stability (very low shrinkage) and no odor or taste. The “putty” consistency refers to a high-viscosity, kneadable base used in a two-step (putty-wash) technique. The kit includes the putty base and catalyst, along with a low-viscosity “light body” or “wash” material for capturing fine details. Key properties include high tear strength, hydrophilicity (to record details in a moist field), and short setting times (often 2-5 minutes).
Industry Standards & Compliance: The FDA 510(k) clearance is a significant differentiator, proving substantial equivalence to a legally marketed predicate device. It also carries the CE mark under the Medical Device Regulation (MDR). It complies with ISO 4823 for dental elastomeric impression materials.
Application Scenarios: Primarily used for:
- Single and multi-unit crown & bridge preparations.
- Implant-level impressions (both open and closed tray).
- Inlay, onlay, and veneer preparations.
- Any situation where absolute accuracy of the marginal seal and internal surface detail is paramount.
Usage Guidelines (Two-Step Technique): 1) Mix equal lengths of putty base and catalyst by kneading for 30-45 seconds until uniform in color. 2) Load into a solid impression tray and seat over the prepared teeth to create a preliminary “putty” impression. 3) After removal and setting, trim away excess material. 4) Inject the low-viscosity wash material around the prepared teeth and re-seat the putty tray (now acting as a custom tray). 5) Hold until the wash material sets.
Market Value Proposition: For the dental professional, this kit mitigates clinical risk. The 510k clearance provides confidence in its reliability. Its high accuracy minimizes remakes, saves chair time, and ensures laboratory-fabricated restorations fit perfectly the first time, leading to superior patient outcomes and practice profitability. For dental suppliers, offering a 510k-cleared material allows you to serve the high-end restorative and specialist market (prosthodontists, implantologists), commanding a premium price and building a reputation for supplying only the most trustworthy, evidence-based products.