CloudPoint FastDesign Chairside
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231529 FDA 510(k)
- FDA Product Code
- PNP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
CloudPoint FastDesign Chairside is a dental abutment design software for dental laboratory use. It is a class II medical device with product code PNP and regulation number 872.3630.
The device received FDA 510(k) clearance (K231529) on March 14, 2024, and was found substantially equivalent to the predicate device Abutment Design (K200100). It is manufactured by Prismatik Dentalcraft, Inc. located in Irvine, California.
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: K231529 - CloudPoint FastDesign Chairside - FDA 510 (k), PDF Prismatik Dentalcraft, Inc. 2144 Michelson Drive Re: K231529 Trade ..., CloudPoint FastDesign Chairside (K231529) — FDA 510(k) | Innolitics, CloudPoint FastDesign Chairside 510 (k) K231529 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231529 | Class II | Active |
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Manufacturer
- Manufacturer
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA 510(k) K231529 24 fields · synced Sep 22, 2026