Zirkonzahn SRL

Certificate 207/MDR

Rev. 4Supplemented

Valid until: Mar 24, 2030

Certificate 207/MDR is a valid Quality management system issued to Zirkonzahn SRL and registered in EUDAMED. Valid until March 24, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 207/MDR
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051207/MDR4

Validity

Issued: Jun 3, 2026
Valid from: Jun 3, 2026
Valid until: Mar 24, 2030

Manufacturer

Manufacturer: Zirkonzahn SRL
Manufacturer SRN: IT-MF-000028795
Manufacturer country: Italy

Notified body

Notified body
Notified body SRN: 0051
Notified body country: Italy

Covered devices

No specific devices are listed for this certificate.

Linked SSCPs

SSCP GS0150ENa-240411

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

207/MDRSupplementedApr 13, 2026 → Mar 24, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa5Class IIb1

6 scopes

Abutment e componenti protesici per implantologia dentale / Abutment and prosthetic components for dental implantology
Class IIb
Strumentazione chirurgica per implantologia dentale / Surgical instruments for dental implantology
Class IIa
Software per la pianificazione di impianti e interventi chirurgici dentali / Software for planning dental implants and surgeries
Class IIa
Ceramiche ed accessori per la colorazione per uso odontoiatrico / Dental ceramics and staining accessories for dental use
Class IIa
Metalli per uso odontoiatrico / Metals for dental use
Class IIa
Resine ed accessori per uso odontoiatrico / Resins and accessories for dental use
Class IIa

Documents

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