DENEB CLASSIC-H

DeneB Classic-H Body Filler

DeneB Classic-H is a cross-linked hyaluronic acid filler from South Korea, supplied in a 10 ml pre-filled syringe for subcutaneous volume correction and body contouring. It is the hard-type version of the DeneB Classic range. For use by licensed physicians only.

Not for facial use, including the cheeks, chin, jawline, fine lines or the lips. DeneB Classic-H is a large-volume body filler.

Key Features

• Large-Volume Syringe: 10 ml pre-filled syringe for body areas.
• Cross-Linked Hyaluronic Acid Micro Beads: Sodium hyaluronate gel, 20 mg/ml. The manufacturer refers to its process as MCL (Multi-staged CrossLinking).
• Hard Type: Classic-H is the hard version; Classic-S is the soft version.
• Reversible: Hyaluronic acid can be dissolved with hyaluronidase by a qualified practitioner.

The DeneB Classic Range

Both products contain 20 mg/ml sodium hyaluronate gel in a 10 ml syringe. The physician selects the product according to the treatment area and the IFU.

• DeneB Classic-S: Soft type.
• DeneB Classic-H: Hard type.

Intended Use

• Subcutaneous volume correction
• Body contouring

Treatment area, injection depth, technique, total volume per session and treatment interval must follow the official Instructions for Use, local regulations and the treating physician’s assessment. Permitted body areas differ between countries. Results and duration vary between individuals.

Product Specifications

• Brand: DeneB
• Product: DeneB Classic-H
• Origin: South Korea
• Composition: Cross-linked sodium hyaluronate gel, 20 mg/ml
• Type: Hard
• Injection Depth: As specified in the IFU
• Contents: 1 × 10 ml pre-filled syringe
• Shelf Life: Refer to the carton for the expiry date.
• Product Type: Hyaluronic acid filler (medical device)

Administration

• For use only by licensed physicians trained in body filler procedures, the relevant anatomy and the management of filler complications.
• Check that the packaging is intact and the product is within its expiry date before use.
• Inject under strict aseptic conditions at the depth specified in the IFU. Inject slowly with low pressure. Avoid large single boluses and overcorrection.
• The needle or cannula, total volume per session and treatment interval must follow the IFU and the treating physician’s judgment.
• Each syringe is for a single patient. Do not self-administer.

Contraindications

General contraindications for hyaluronic acid fillers are listed below. Refer to the official Instructions for Use for the complete list.

• Known hypersensitivity to hyaluronic acid or any component of the product
• History of severe allergies or anaphylaxis
• Active infection, inflammation, wounds or skin disease at or near the injection site
• Pregnancy or breastfeeding
• Persons under 18 years of age

Who Should Consult a Physician First

• People with autoimmune disease or diabetes
• People with bleeding disorders or taking anticoagulant or antiplatelet medication
• People with a tendency to hypertrophic scars or keloids
• People with permanent fillers, implants or previous surgery in the treatment area

Precautions

• Common reactions include redness, swelling, pain, tenderness and bruising at the injection site.
• Large-volume injection may be associated with lumps, nodules, encapsulation, asymmetry, product migration, infection and delayed inflammatory reactions. A firmer gel may be more palpable, especially in thin tissue.
• Accidental injection into a blood vessel can cause vascular occlusion or embolism and tissue damage. Deep body areas with large vessels require particular care.
• Hyaluronic acid filler in breast tissue can interfere with breast imaging, including mammography. Patients should tell their doctor or radiologist about any previous filler treatment.
• Hyaluronic acid can be dissolved with hyaluronidase. Practitioners should keep hyaluronidase and an emergency protocol available.
• Seek medical attention immediately for severe or increasing pain, skin colour change, fever, chest pain or shortness of breath after treatment.
• Do not use if the packaging is open or damaged, the syringe is cracked or the product is past its expiry date.
• Single use only. One syringe, one patient. Do not re-sterilise. Keep out of reach of children.

After Treatment

Follow the aftercare instructions given by the treating physician. Strenuous exercise, heat exposure and pressure or massage on the treated area are generally avoided in the first days, unless the physician advises otherwise. Report any adverse reaction to the treating physician.

Storage

Store as indicated on the carton. Protect from direct sunlight and freezing. Refer to the carton for the expiry date.

Package Contents

• 1 × 10 ml pre-filled syringe of DeneB Classic-H
• Instructions for Use

Important Notice

For professional healthcare use only. This information is for general product reference. It does not replace medical advice, the official Instructions for Use or local regulations. This product is not intended to diagnose, treat, cure or prevent any disease. Results vary between individuals.