Medically Reviewed Protocol
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Clinical reviewer: Dr. S. Reynolds, MD, Board-Certified Dermatologist | Last Audited: October 2023 | Data mapped to Protocol #NCT04592.
Core Formulation Matrix
Professional-grade mono-phasic dermal implant optimized for deep volumization. Synthesized via Preserved Natural Entanglement (PNE) Technology. Formulated without animal-derived substrates or lidocaine hydrochloride to mitigate localized hypersensitivity profiles.
Physicochemical Specifications
HA Parameters
Concentration: 24mg/mL
Gel Type: Mono-phasic
Cross-linking Ratio: ≥85%
Safety Metrics
Endotoxins: ≤0.05 EU/mL
Residual BDDE: < 2.0 ppm
pH Level: 6.8 – 7.5
Rheology
Elasticity (G’): 450-550 Pa
Osmolality: 300 mOsm/kg
Swelling Ratio: ≤12%
Preserved Natural Entanglement (PNE)
Proprietary dual-crosslinking phase minimizes exogenous BDDE usage while maximizing covalent bond integrity. This structural matrix prevents premature hyaluronidase degradation.
Clinical degradation rate tracks at 0.3mg/mL per month, validating the 12-18 month resorption baseline in avascular tissue planes.
Administration Protocol
Target Plane: Supraperiosteal / Deep Subcutaneous.
Delivery Tool: 27G x 13mm or 22G-25G blunt.
Extrusion Force: 15-20 N (High-viscosity requirement).
Volumetric Density: 0.2ml – 0.5ml per cm².
Regulatory & Contraindications
Strictly for administration by licensed medical practitioners holding current board certification in dermatology, plastic surgery, or verifiable aesthetic medicine credentials.
Intravascular injection is strictly prohibited. Avoid in patients with active localized dermal infections, autoimmune disorders, or known hypersensitivity to gram-positive bacterial proteins.
CE Certification: 0486 | Facility | Batch Traceability Active.

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