← Product Code [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI) · K010800 # VERSYO.COM (K010800) _Heraeus Kulzer, Inc. · EBI · May 31, 2001 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K010800 ## Device Facts - **Applicant:** Heraeus Kulzer, Inc. - **Product Code:** [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI.md) - **Decision Date:** May 31, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3760 - **Device Class:** Class 2 - **Review Panel:** Dental ## Regulatory Identification A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K010800](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K010800) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K010800