← Product Code [ELM](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM) · K011130

# PREMIUM (K011130)

_Heraeus Kulzer, Inc. · ELM · Jul 5, 2001 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K011130

## Device Facts

- **Applicant:** Heraeus Kulzer, Inc.
- **Product Code:** [ELM](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM.md)
- **Decision Date:** Jul 5, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3590
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K011130](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELM/K011130)

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