← Product Code [EFH](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH) · K864572

# FIXTECTOR (K864572)

_Prodent Intl., Inc. · EFH · Feb 12, 1987 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K864572

## Device Facts

- **Applicant:** Prodent Intl., Inc.
- **Product Code:** [EFH](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH.md)
- **Decision Date:** Feb 12, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6140
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

Articulation paper is a device composed of paper coated with an ink dye intended to be placed between the patient's upper and lower teeth when the teeth are in the bite position to locate uneven or high areas.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K864572](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K864572)

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