Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3830](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3830) → EKN — Point, Paper, Endodontic

# EKN · Point, Paper, Endodontic

_Dental · 21 CFR 872.3830 · Class 1_

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

## Overview

- **Product Code:** EKN
- **Device Name:** Point, Paper, Endodontic
- **Regulation:** [21 CFR 872.3830](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3830)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

An endodontic paper point is a device made of paper intended for use during endodontic therapy to dry, or apply medication to, the root canal of a tooth.

## 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.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K843017](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKN/K843017.md) | ABSORBENT ENDODONTIC POINT | United Dental Mfg., Inc. | Jan 9, 1985 | SESE |
| [K821625](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKN/K821625.md) | ENDODONTIC PAPERPOINTS | Roeko | Jun 14, 1982 | SESE |
| [K812886](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKN/K812886.md) | ENDODONTIC PAPER POINTS | United Dental Mfg., Inc. | Nov 16, 1981 | SESE |
| [K800827](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKN/K800827.md) | PREMIER ABSORBENT POINTS | Premier Dental Products Co. | Apr 29, 1980 | SESE |
| [K781605](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKN/K781605.md) | R&R ABSORBENT POINTS | Ransom and Randolph | Oct 10, 1978 | SESE |
| [K761203](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKN/K761203.md) | ABSORBENT POINTS | Johnson & Johnson Professionals, Inc. | Dec 13, 1976 | SESE |
| [K760983](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKN/K760983.md) | ENDODONTIC INSTRUMENTS | Adp Intl., Inc. | Nov 15, 1976 | SESE |

## Top Applicants

- United Dental Mfg., Inc. — 2 clearances
- Adp Intl., Inc. — 1 clearance
- Johnson & Johnson Professionals, Inc. — 1 clearance
- Premier Dental Products Co. — 1 clearance
- Ransom and Randolph — 1 clearance

---

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

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