Surgeine Healthcare is a trusted international manufacturer specializing in precision-engineered, single-use dental surgical kits and specialized drape sets. Produced in ISO Class 8 cleanrooms and sterilized using validated Ethylene Oxide (EO) processes, our dental kits streamline clinical workflow, safeguard the sterile field, and eliminate cross-contamination risks across oral surgery, implantology, and periodontics.
Designed in compliance with international standards including ISO 13485:2016 and EU MDR 2017/745, our custom procedure packs integrate high-barrier nonwoven materials, fluid-repellent draping, and specialized protective apparel. We partner with overseas group purchasing organizations (GPOs), medical device importers, and dental hospital networks to supply reliable OEM and private-label solutions.
Every kit configuration is meticulously combined with medical-grade components to optimize setup times and ensure strict aseptic conditions.
Specifically assembled for complex dental implant and bone grafting procedures. Includes specialized oral drapes with integrated fluid collection, adhesive apertures, and tube holders to maintain a sterile barrier during drilling and restoration.
Tailored for maxillo-facial surgeons and oral clinicians. Features fluid-resistant SMS surgical gowns (AAMI PB70 Level 2/3), absorbent hand towels, head covers, and surgical masks for complete personal protection.
Consolidates essential sterile disposables for tooth extractions, root canal therapy, and periodontal treatments. Supports non-touch techniques, reduces preparation time, and minimizes packaging waste.
Provides complete head-to-toe protective apparel for dental assistants and surgical staff. Formulated to resist fluid splatters and bio-aerosols generated during high-speed dental procedures.
Includes sterile light handle sleeves, camera wraps, unit handle covers, and hose sheaths. Ensures full sterility of non-autoclavable dental chair equipment and imaging devices.
Pre-assembled single-use kit for routine oral examinations, hygiene cleanings, and diagnostic consultations. Cost-effective solution that guarantees standard hygienic practices for every patient.
We supply global buyers with full transparency regarding raw material specifications, barrier classification, and packaging compliance.
| Kit Designation | Core Components | Material & Barrier Level | Clinical Target Application |
|---|---|---|---|
| Dental Implantology Pack | 1 Patient Drape with aperture, 1 Back Table Cover, 2 Light Handle Covers, 2 Hand Towels, 1 Saliva Ejector Sheath | SMS / Bi-Laminate Nonwoven (AAMI Level 3), Fluid Impermeable | Implant placement, sinus lifts, bone grafting procedures |
| Dental Surgeon Kit | 1 Reinforced Surgical Gown, 1 Surgical Cap, 1 Anti-Fog Face Mask, 2 Absorbent Towels | Breathable SMS / SMMS Fabric (EN 13795 High Performance) | Oral surgeons, surgical assistants, perioperative staff |
| Minor Dental Surgery Kit | 1 Patient Aperture Drape (U-shape/Oval), 1 Utility Drape, 1 Mayo Stand Cover, 1 Tray Cover | Hydrophilic / Hydrophobic Poly-Laminate, Lint-Free | Surgical extractions, gingivectomy, endodontics |
| Dental Equipment Sheath Kit | 2 Handle Covers, 1 C-Arm / X-Ray Sleeve, 1 Control Panel Film, 2 Tubing Sheaths | PE Film / Transparent Polyurethane, Latex-Free | Surfaces and equipment shielding within the sterile zone |
Built on 20+ years of healthcare manufacturing excellence, Surgeine provides robust OEM capabilities, supply chain security, and regulatory documentation.
Manufactured under ISO 13485:2016 management systems and CE MDR criteria, complete with technical dossiers for fast-track regional registration.
Custom component layout, folding order, drape sizing, multi-language pouch printing, and tailored carton packaging designed for your brand.
Validated Ethylene Oxide (EO) sterilization (ISO 11135) ensuring SAL 10^-6, supported by in-house cytotoxicity and bioburden testing protocols.
All component assembly and primary packaging are conducted inside controlled ISO Class 8 (Class 100,000) cleanroom facilities.
Star Export House supplying medical distributors, hospital tenders, and dental networks across 25+ countries in Europe, LATAM, Middle East, and Asia.
Vertical manufacturing capability—from fabric lamination to sterile pouch sealing—delivers competitive bulk pricing without quality compromises.
Yes. Surgeine Healthcare operates under an ISO 13485:2016 quality management system. Our sterile dental surgical packs carry CE marking compliant with EU MDR 2017/745 standards. We supply complete regulatory dossiers, sterilization certificates, and Declarations of Conformity required for customs clearance and health authority registration.
Absolutely. We specialize in OEM and private-label manufacturing for global distributors. You can customize drape dimensions, aperture sizes, gown barrier levels, component loading sequence, sterile pouch artwork, and carton packaging to meet local market needs or tender specifications.
Our dental kits undergo Ethylene Oxide (EO) sterilization processed under strict ISO 11135 guidelines. The standard shelf life is 3 to 5 years from the date of manufacture, provided the sterile barrier pouch remains intact and undamaged.
Every production lot undergoes rigorous quality checks in our internal testing laboratory, evaluating barrier resistance, seal strength, particle linting, and burst pressure. We maintain full lot traceability and retain production samples for every shipped batch.
Looking for reliable OEM/ODM supply, custom dental kit configurations, or competitive bulk quotations for your distribution network? Connect directly with our international medical exports team today.
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