CE-approved cross-linked hyaluronic acid body filler for non-surgical body contouring
Certifications
CE Class III medical device certification for hyaluronic acid body filler applications.
Manufactured under ISO 13485 Certified quality management system for medical devices.
Manufactured in a KGMP Compliant (Korean Good Manufacturing Practice) facility as declared by BioPlus.
Complies with applicable European medical device regulations for sterile injectable implants at the time of certification.
CE Class III medical device certification for hyaluronic acid body filler applications.
Manufactured under ISO 13485 Certified quality management system for medical devices.
Manufactured in a KGMP Compliant (Korean Good Manufacturing Practice) facility as declared by BioPlus.
Complies with applicable European medical device regulations for sterile injectable implants at the time of certification.
Non Animal Origin hyaluronic acid with purification processes designed to minimise residual impurities as part of MDM technology.
Description
DeneB Classic-S Body Filler is a CE-approved, large-volume (1 x 10 ml) cross-linked hyaluronic acid (HA) dermal filler developed by BioPlus Co., Ltd. for non-surgical body contouring. It is specifically designed to volumize and reshape areas such as the buttocks, hips and breasts, and can also be used for general body contouring in other suitable regions. The filler consists of a cross-linked polymeric form of hyaluronic acid immobilised on small particle surfaces and manufactured using BioPlus MDM/MCL multi-level crosslinking technologies, creating a cohesive, highly viscoelastic gel that maintains a stable shape with low migration. With an HA concentration of 20 mg/ml and an optional lidocaine (0.3%, 3 mg/ml) variant, DeneB Classic-S provides long-lasting, natural-looking volume and contouring with typical results lasting around 12–16 months, depending on treatment area and patient factors.
Bnefits
CE-approved hyaluronic acid body filler designed for non-surgical body contouring and volume restoration.
Large 10 ml syringe volume optimised for body indications such as buttocks, hips and breasts.
Cross-linked polymeric hyaluronic acid immobilised on small particle surfaces for deep, stable volumisation.
Medium viscoelasticity and high cohesiveness provide a soft, natural feel with good molding characteristics and low migration.
MDM/MCL multi-level crosslinking technology based on DVS (divinyl sulfone) supports durable shaping and long-lasting results.
Typical duration of effect of approximately 12–16 months, varying by treated area, technique and patient metabolism.
Hyaluronic acid is non-animal sourced, reducing risk of immunogenic reactions and disease transmission.
Formulated to support hydration and collagen stimulation in treated tissues for improved skin quality over time.
Can be used for non-surgical buttock enhancement to achieve a firm yet natural look in appropriate candidates.
Supplied as a pre-filled syringe for convenient, controlled implantation by trained healthcare professionals.
Indications
Non-surgical body contouring using cross-linked hyaluronic acid filler.
Non Animal Origin hyaluronic acid with purification processes designed to minimise residual impurities as part of MDM technology.
CE-approved cross-linked hyaluronic acid body filler for non-surgical body contouring
Breast enhancement (non-surgical volume improvement) in suitable patients.
Hips sculpting and correction of hip dips.
General body contouring and volume restoration in areas such as outer thighs, calves or other approved regions at the clinician’s discretion.
Improvement of body silhouette and proportional balance without surgical implants.
Composition
Main ingredient: Cross-linked hyaluronic acid 20 mg/ml (sodium hyaluronate) in a cohesive gel matrix.
Some DeneB Classic-S variants include Lidocaine 0.3% (3 mg/ml) for local anaesthetic effect; other marketed variants are lidocaine-free – check specific packaging.
Hyaluronic acid described as glucosamine consisting of disaccharide units of D-glucuronic acid and N-acetyl-D-glucosamine.
Non-animal-origin hyaluronic acid, purified to remove harmful residues as part of the MDM purification process.
Sterile, pyrogen-free, viscoelastic HA gel formulated for injection into mid-to-deep dermis or subcutaneous tissue in body areas.
Formulation
Injectable, sterile, apyrogenic, cross-linked hyaluronic acid gel for single-use only.
Body filler formulation with medium viscoelasticity (typical injection force approximately 49–52 N) to allow molding with good tissue integration.
High-cohesion monophasic-type gel created using proprietary MDM (Multiple crosslinking & Dense Matrix) and MCL (Multi-Level Crosslinking) technologies.
Designed specifically for body contouring indications rather than routine facial fine line correction.
Available as both lidocaine-free and lidocaine-containing variants depending on distributor and market.
Packaging
1 x 10 ml pre-filled sterile syringe of DeneB Classic-S body filler per box.
Supplied without needles; appropriate sterile needles or cannulas are selected separately according to the treatment protocol.
Outer carton includes product name, batch/lot number, expiry date, CE mark and manufacturer details (BioPlus Co., Ltd.).
Syringe includes tamper-evident seals and Luer-lock connection to allow secure attachment of needles or cannulas.
Shelf life typically 24 months from date of manufacture when stored under recommended conditions.
Usage
DeneB Classic-S must only be used by appropriately trained and qualified healthcare professionals experienced in hyaluronic acid body filler techniques.
Before use, confirm the integrity of the packaging, check the expiry date and inspect the syringe and gel for any visible defects; do not use if compromised.
Perform a full medical history and physical examination, including assessment of indications, contraindications and patient expectations, and obtain informed consent.
Treat according to the official instructions for use (IFU) supplied by the manufacturer, including recommended injection planes (typically deep dermis or subcutaneous tissue) and volumes appropriate for the treatment area.
Use strict aseptic technique; disinfect the treatment area and observe standard precautions to minimise infection risk.
Inject slowly and carefully, avoiding intravascular injection; aspirate in accordance with clinic protocols and monitor tissue response throughout the procedure.
After injection, gently mould and shape the treated area to achieve the desired contour, respecting product-specific guidance on molding and massage.
Advise the patient on post-treatment care, including avoiding excessive pressure, strenuous exercise, heat exposure (e.g. saunas) and alcohol for a recommended period, and monitoring for signs of complications.
Do not re-sterilise or reuse any part of the syringe; dispose of used syringes, needles and cannulas as clinical sharps waste in accordance with local regulations.
In case of suspected adverse events or complications (e.g. infection, nodules, vascular compromise), follow local emergency protocols and product IFU guidance, and consider consultation with appropriate specialists.
Contraindications
Known hypersensitivity or allergy to hyaluronic acid, lidocaine (where applicable) or any other component of the product.
History of severe anaphylactic reactions or multiple severe allergies to injectable products.
Presence of active infection, inflammation, skin disease or wounds at or near the intended injection site.
Tendency to develop hypertrophic scars or keloids in the proposed treatment area without careful risk–benefit assessment.
Autoimmune diseases or immunosuppression where dermal filler use is considered high risk, unless clearly justified and managed by an experienced clinician.
Pregnancy or breastfeeding, as safety data are lacking; use is generally not recommended.
Concurrent use of certain anticoagulants or antiplatelet agents may increase bruising risk and should be assessed; adjust timing or avoid where clinically indicated.
Previous placement of permanent or incompatible fillers in the intended treatment area unless carefully evaluated by an expert injector.
Adverse Effects
Common, usually transient reactions at the injection site such as redness (erythema), swelling, tenderness, pain, bruising, itching or firmness.
Localised lumps, nodules or asymmetry, sometimes requiring massage, medical management or, in rare cases, hyaluronidase treatment if appropriate.
Infection at the injection site or deeper tissues, requiring medical evaluation and treatment.
Hypersensitivity or allergic reactions, ranging from local inflammatory responses to rare systemic reactions.
Tyndall effect or visible irregularities if the product is placed too superficially.
Rare but serious complications associated with injectable hyaluronic acid fillers, including vascular occlusion, tissue ischaemia and necrosis, or embolic events affecting vision or other organs; these require urgent recognition and management by experienced clinicians.
Delayed inflammatory reactions or granuloma formation, which may require prolonged follow-up and specific medical treatment.
Storage Conditions
Store in accordance with the manufacturer’s instructions, typically at controlled room temperature (for most HA fillers commonly 2–25°C) away from direct sunlight and moisture.
Do not freeze the product and avoid exposing it to excessive heat, as extreme temperatures may degrade the hyaluronic acid gel.
Keep the syringe in its original packaging until immediately before use to maintain sterility and protect from physical damage and light.
Do not use the product after the expiry date printed on the packaging.
Store out of the reach of children and unauthorised persons in a secure medical storage area.
Duration
Clinical and marketing data indicate that results generally last around 12\u201316 months for body contouring indications, though duration varies with patient metabolism, treatment area, injection technique and volume used.
Onset
Volumising and contouring effects are visible immediately after injection, with final results stabilising over the following days to weeks as any procedure-related swelling resolves and the filler integrates with the surrounding tissues.
