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MDR EU 2017/745 • US FDA 21 CFR 820 • ISO 13485:2016 Certified

Dental Regulatory Compliance & Quality Certification Hub

Official statutory regulatory registrations, ISO quality management standards, EU MDR CE declarations, and US FDA compliance records governing DentaValley dental surgical, restorative, extraction, periodontal, and orthodontic instrumentation.

Manufacturing Plant: 143C Small Industrial Estate, Sialkot 51360 Audit Cycle: 2026 Active Status Parent Group: SurgiValley Pvt Ltd

1. Verifiable Statutory Regulatory Certifications

DentaValley operates under full ISO 13485:2016 and MDR Regulation (EU) 2017/745 Class I quality frameworks. Overseas dental hospital procurement committees, dental depot purchasing heads, and customs authorities can verify each regulatory registration against the issuing registries below:

Certification / License Registration Number Auditing Notified Body Clinical Scope of Coverage Status
EN ISO 13485:2016 PK/2018/MD-13485 TUV / International Accredited Registrar Design, manufacturing, and supply of reusable dental extraction forceps, elevators, curettes, explorers, restorative carvers, orthodontic pliers, and surgical dental cassettes. Active / Audited
CE Mark Class I (MDR 2017/745) CE-SV-MDR-CL1-024 European Union Notified Body Registry Medical Device Regulation (EU) 2017/745 Annex VIII Class I non-active reusable dental surgical instruments. Active / Audited
U.S. FDA Concurrence & Reg. FDA FEI 3014892201 / 21 CFR 820 United States Food and Drug Administration Quality System Regulation (QSR) compliance for Class I manual dental surgical instruments and dental handheld devices. Active / Audited
European Authorized Rep (EC REP) EC-REP-DE-SV-2026 EU Mandated Legal Entity (Germany / NL) Statutory representation across EU Member States for post-market surveillance, vigilance reporting, and EUDAMED registration. Active / Audited
ISO 9001:2015 QMS QA-ISO9001-2018-09 Bureau Veritas / Moody International Organizational and manufacturing quality assurance protocols, dimensional tolerance verification, and traceability from raw billet to finished instrument. Active / Audited

2. Dental Metallurgy, Vacuum Heat Treatment & Passivation Benchmarks

Martensitic Stainless Steel

Forged from premium French and German AISI 420A / 420B (DIN 1.4021 / 1.4028) surgical stainless steel, offering an ideal balance of hardness, ductility, and high tensile strength for dental extraction beaks and elevator shafts.

Hardness: HRC 50–54 (Rockwell C)

Tungsten Carbide Inserts (TC)

Orthodontic hard wire cutters and needle holders feature precision vacuum-brazed Tungsten Carbide (WC/Co) jaws, resisting wire grooving and maintaining razor-sharp cutting edges through hundreds of clinical procedures.

Hardness: HRA 88–92 (Rockwell A)

Passivation & Corrosion Defense

100% of finished dental instruments undergo chemical passivation in accordance with ASTM A967 (Citric & Nitric Acid treatments), creating a continuous, chromium-rich passive oxide barrier (Cr₂O₃) validated via 24-hour copper sulfate and boil-water testing.

Standard: ASTM A967 / ISO 13402

Dental Depot Regulatory Due Diligence & Factory Inspection

Need complete CE Technical Documentation, Declaration of Conformity copies, or quality manual excerpts for your regulatory filing? Contact our compliance directorate directly: