← Product Code [ELS](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS) · K811209

# JACOB WIRZ TRANSFIXATION PIN (K811209)

_Colmed, Ltd. · ELS · Jun 16, 1981 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS/K811209

## Device Facts

- **Applicant:** Colmed, Ltd.
- **Product Code:** [ELS](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS.md)
- **Decision Date:** Jun 16, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3890
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An endodontic stabilizing splint is a device made of a material, such as titanium, intended to be inserted through the root canal into the upper or lower jaw bone to stabilize a tooth.

## 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/ELS/K811209](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELS/K811209)

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