Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6140](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6140) → EFH — Paper, Articulation

# EFH · Paper, Articulation

_Dental · 21 CFR 872.6140 · Class 1_

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

## Overview

- **Product Code:** EFH
- **Device Name:** Paper, Articulation
- **Regulation:** [21 CFR 872.6140](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6140)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)
- **GMP exempt:** yes

## 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.

## Classification Rationale

Class I (general 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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K965026](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K965026.md) | PFINGST PRESSURE PASTE | Pfingst & Co., Inc. | Feb 10, 1997 | SESE |
| [K912632](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K912632.md) | OCCLUDE | Pascal Co., Inc. | Jan 17, 1992 | SESE |
| [K911259](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K911259.md) | HYDENT | Pascal Co., Inc. | Jun 6, 1991 | SESE |
| [K864572](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K864572.md) | FIXTECTOR | Prodent Intl., Inc. | Feb 12, 1987 | SESE |
| [K870032](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K870032.md) | REVISED T-SCAN SYSTEM | Sentek, Inc. | Feb 2, 1987 | SESE |
| [K832647](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K832647.md) | ARTICULATING PAPER | Ardent Intl., Inc. | Feb 21, 1984 | SESE |
| [K833132](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K833132.md) | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | Myo-Tronics Research, Inc. | Feb 10, 1984 | SESE |
| [K810498](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K810498.md) | CENTRIC (BITE) REGISTRATION PASTE | Wallace A. Erickson & Co. | Mar 17, 1981 | SESE |
| [K771011](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K771011.md) | ARTICULATING PAPER | Parker Laboratories, Inc. | Jun 20, 1977 | SESE |
| [K770492](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFH/K770492.md) | CRACK DETECTOR, DEN-MAT | Dey-Mat, Inc. | Mar 21, 1977 | SESE |

## Top Applicants

- Pascal Co., Inc. — 2 clearances
- Ardent Intl., Inc. — 1 clearance
- Dey-Mat, Inc. — 1 clearance
- Myo-Tronics Research, Inc. — 1 clearance
- Parker Laboratories, Inc. — 1 clearance

---

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

**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:** Innolitics at https://innolitics.com