Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3840](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3840) → EKL — Point, Silver, Endodontic

# EKL · Point, Silver, Endodontic

_Dental · 21 CFR 872.3840 · Class 1_

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

## Overview

- **Product Code:** EKL
- **Device Name:** Point, Silver, Endodontic
- **Regulation:** [21 CFR 872.3840](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3840)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

An endodontic silver point is a device made of silver intended for use during endodontic therapy to fill permanently 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K992582](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKL/K992582.md) | PACIFIC IMPLANT TITANIUM ENDODONTIC POINT | Pacific Implant, Inc. | Oct 21, 1999 | SESE |
| [K961089](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKL/K961089.md) | PULPDENT ENDOPREP II | Pulpdent Corp. | Apr 23, 1996 | SESE |
| [K822568](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKL/K822568.md) | EAR PROBES | Kelleher Corp. | Sep 14, 1982 | SESE |

## Top Applicants

- Kelleher Corp. — 1 clearance
- Pacific Implant, Inc. — 1 clearance
- Pulpdent Corp. — 1 clearance

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

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