← Product Code [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF) · K010250 # TETRIC CERAM HB (K010250) _Ivoclar North America, Inc. · EBF · Feb 28, 2001 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K010250 ## Device Facts - **Applicant:** Ivoclar North America, Inc. - **Product Code:** [EBF](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF.md) - **Decision Date:** Feb 28, 2001 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3690 - **Device Class:** Class 2 - **Review Panel:** Dental ## Regulatory Identification Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K010250](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBF/K010250) **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/EBF/K010250