Identity
- Trade Name
- FREEALGIN EUDAMED
- Device Name
- VPS0 EUDAMED
- Model / Reference
- C300110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056000371314 EUDAMED
- Basic UDI-DI
- 805600037VPS0BD EUDAMED
- 510(k) Number
- K070700 FDA 510(k)
- FDA Product Code
- ELW FDA 510(k)
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3660 FDA 510(k)
- Regulation Number
- 872.3660 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Freealgin is a medium viscosity addition silicone used for preliminary impression taking in dental procedures. It serves as a substitute for traditional alginates and offers high dimensional stability, ensuring flexibility in impression casting times and greater accuracy.
The device is supplied as a vinylpolysiloxane material for preliminary impressions. It is authorized under FDA 510K and MDR regulations. The device is available in various sizes and is designed for dental use, with no specific information regarding sterility, single-use or reusable status, or MRI safety provided in the data.
Frequently asked questions
What is Freealgin used for in dental procedures?
Freealgin is a medium viscosity addition silicone used for preliminary impression taking in dental procedures, serving as a substitute for traditional alginates.
How is Freealgin supplied?
The device is supplied as a vinylpolysiloxane material specifically designed for preliminary impressions in dental applications.
What regulatory approvals does Freealgin have?
Freealgin is authorized under FDA 510K and MDR regulations, indicating it meets certain regulatory requirements for dental impression materials.
Is Freealgin available in different sizes?
The device is available in various sizes to accommodate different dental impression needs, though specific size details are not provided in the data.
What are the key features of Freealgin?
Freealgin offers high dimensional stability, ensuring flexibility in impression casting times and greater accuracy compared to traditional alginates.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Freealgin - Zhermack, ZHERMACK FREEALGIN MANUAL Pdf Download | ManualsLib, Zhermack freealgin Manuals | ManualsLib
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K070700 | Class II | Active |
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Manufacturer
- Manufacturer
- Zhermack S.P.A.
Sources (2)
- FDA 510(k) K070700 24 fields · synced Sep 18, 2026
- EUDAMED cd9bf8f7-cfa4-43b2-9e31-851a13e5695d 61 fields · synced Jul 8, 2026