Spectra Form Chromatic Alginate Impression Material
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K980965 FDA 510(k)
- FDA Product Code
- ELW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3660 FDA 510(k)
- Regulation Number
- 872.3660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Spectra Form Chromatic Alginate Impression Material is a dental impression material used to capture oral cavity anatomy for gypsum cast construction. It is a chromatic alginate that undergoes a color-changing process when mixed with water: violet upon initial mixing, pink at the end of mixing time, and off-white at the end of setting time in the mouth, guiding clinical workflow.
It is supplied as a material for use by dental professionals in clinical settings. The device is a single-use impression material, non-sterile, and not MRI safety evaluated. It is authorized under FDA 510(k) clearance K980965 with product code ELW and regulation number 872.3660, classified as a Class II device.
Manufacturer's product page: Cavex Impressional
Frequently asked questions
What is Spectra Form Chromatic Alginate Impression Material used for?
It is used to capture oral cavity anatomy for the construction of gypsum casts in dental clinical settings, enabling accurate impressions for prosthetics and diagnostics.
How is Spectra Form Chromatic Alginate Impression Material supplied and is it sterile?
It is supplied as a non-sterile, single-use impression material intended for use by dental professionals; it is not provided in sterile packaging and is designed for one-time use per patient.
What does the color change in Spectra Form Chromatic Alginate indicate during use?
The material turns violet when initially mixed with water, pink at the end of the mixing time, and off-white when fully set in the mouth, providing visual cues to guide the clinician through each stage of the impression process.
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: Spectra Form Chromatic Alginate Impression Material, PDF K980965 - Spectra Form Chromatic Alginate Impression Material, SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL 510 (k) K980965 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K980965 | Class II | Active |
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Manufacturer
- Manufacturer
- Cavex Holland BV
Sources (1)
- FDA 510(k) K980965 24 fields · synced Sep 22, 2026