← Product Code [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI) · K253681

# TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) (K253681)

_Graphy, Inc. · EBI · Nov 21, 2025 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K253681

## Device Facts

- **Applicant:** Graphy, Inc.
- **Product Code:** [EBI](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI.md)
- **Decision Date:** Nov 21, 2025
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3760
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** 3rd-Party Reviewed

## 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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K253681](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBI/K253681)

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