Geistlich GEM21S:Growth-Factor Enhanced Matrix Kit 0.5cc BTCP/0.5 ml rhPDGF, 1cup and 1 vial/kit

Handling:

1. Material Preparation:
   • GEM 21S comes as a kit with two sterile components: a cup containing beta-tricalcium phosphate (β-TCP) particles and a syringe with rhPDGF-BB solution.
   • Use aseptic techniques to transfer the particles into a sterile field and mix them with the rhPDGF-BB solution.
   • Allow the particles to hydrate for 10 minutes before application.
2. Storage:
   • Store the GEM 21S kit at 2°–8°C (36°–46°F) in a dry place; do not freeze.
   • β-TCP particles can be stored at room temperature (up to 30°C/86°F), but rhPDGF-BB must remain refrigerated and protected from light.
3. Surgical Technique:
   • Prepare the surgical site by removing granulation tissue and thoroughly debriding the defect.
   • Place hydrated GEM 21S into the defect with moderate pressure, ensuring direct contact with well-vascularized bone. Avoid overfilling.

Precautions:

1. Contraindications:
   • Do not use in sites with untreated infections, cancer, hypersensitivity to components, or if soft tissue coverage is not achievable.
   • Not for use in skeletally immature patients (<18 years).
2. Warnings:
   • GEM 21S is for single use only; discard any unused material.
   • The kit components must be used together and not separately.
   • Only for periodontal-related defects; not for systemic use.

Indications:

GEM 21S® is ideal for treating: Augmentation or reconstructive treatment of the alveolar ridge; filling of periodontal defects, peri-implant defects in conjunction with products intended for GBR, and extraction sockets to enhance preservation of the alveolar ridge and bone defects in conjunction with Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); elevation of the maxillary sinus floor; and Gingival recession associated with periodontal disease.

GEM 21S is a kit of two sterile components:

1. One cup containing 0.5 cc of scaffold (synthetic beta-tricalcium phosphate (β-TCP) [Ca₃(PO₄)] particles)
2. 0.5 ml syringe of 0.3 mg/mL rhPDGF-BB in 20 mmol sodium acetate buffer pH 6, a highly purified, recombinant human platelet-derived growth factor