Regulatory Status & Intended Use
Last updated on June 10, 2026
Last reviewed on June 10, 2026
This page describes the regulatory status and intended use of RapidArch in the United States. It is provided for transparency to the licensed dental professionals who use the software and does not replace the professional judgment of the treating clinician.
1. Regulatory status (United States)
RapidArch’s All-on-X implant-restoration design features are under development. They have not been cleared or approved by the U.S. Food and Drug Administration (FDA) and are not represented as FDA-cleared or FDA-approved. Nothing on this website should be read as a claim of FDA clearance, approval, or endorsement.
Other features that do not design an implant-borne restoration (for example, general visualization or design of restorations on natural teeth) may be subject to different regulatory requirements. Where a feature is offered for evaluation, demonstration, or non-clinical use only, that limitation is stated at the point of use.
2. Intended use
RapidArch is intended as a computer-aided design (CAD) aid for trained dental professionals to design patient-specific, screw-retained interim (provisional) full-arch fixed dental prostheses, for immediate loading, that seat on legally marketed multi-unit abutments (abutment-level restorations). The software produces a digital design file intended to be manufactured from a legally marketed, biocompatible interim restorative material using a validated process, and delivered by a licensed dental professional.
RapidArch is a design aid. It does not diagnose disease, does not plan or guide surgical implant placement, and is not intended for the design of implant-level (direct-to-implant) restorations, custom abutments that interface directly with the dental implant, or definitive (final) prostheses. The treating clinician is responsible for reviewing and verifying every design and for the fit, occlusion, and function of the final restoration, including verifying passive seating and tightening prosthetic screws to the multi-unit abutment manufacturer’s specifications.
3. Prescription / professional use
RapidArch is intended for use only by, or on the order of, licensed dental professionals and members of their team acting under their supervision. It is not intended for use by patients or the general public. Once cleared, applicable prescription (Rx) statements will be added to this page and to product labeling.
4. Availability by region
Regulatory requirements differ by country. The statements on this page address the United States. Availability and permitted use of RapidArchvary by jurisdiction, and not all features are available in all markets. It is the user’s responsibility to ensure that their use complies with the laws and regulations applicable in their location.
5. Manufacturer
RapidArch LLC. Device identifier and version information are shown within the software.
6. Reporting a problem
To report a malfunction, a quality concern, or a suspected adverse event involving RapidArch, contact info@rapidarch.com. Reports are reviewed under our complaint-handling process. Reporting a problem to us does not replace any reporting obligation a clinician or facility may have to a regulatory authority.
7. Changes
RapidArchmay update this page as the product and its regulatory status evolve. The current version is identified by the “last updated” date above.
8. Contact
Questions about this page should be sent to info@rapidarch.com.