Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4565](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4565) → EKR — Plugger, Root Canal, Endodontic

# EKR · Plugger, Root Canal, Endodontic

_Dental · 21 CFR 872.4565 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKR

## Overview

- **Product Code:** EKR
- **Device Name:** Plugger, Root Canal, Endodontic
- **Regulation:** [21 CFR 872.4565](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4565)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.

## Classification Rationale

Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K060347](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKR/K060347.md) | B&L L-BETA, MODEL WL-B1 | B&L Biotech Co., Ltd. | Jun 5, 2006 | SESE |
| [K042828](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKR/K042828.md) | OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 | Young O/S, LLC | Dec 1, 2004 | SESE |
| [K031664](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKR/K031664.md) | ELEMENTS OBTURATION UNIT | Sybron Endo/Analytic | Apr 28, 2004 | SESE |
| [K860569](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKR/K860569.md) | ENDODONTIC ROOT CANAL PLUGGER | Dentsply Intl. | Mar 26, 1986 | SESE |
| [K831748](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKR/K831748.md) | ENDODONTIC ROOT CANAL PLUGGER FINGER- | Union Branch | Jul 12, 1983 | SESE |
| [K791019](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKR/K791019.md) | MCSPADDEN CONDENSOR | Techdent, Inc. | Aug 3, 1979 | SESE |

## Top Applicants

- Young O/S, LLC — 1 clearance
- Union Branch — 1 clearance
- Techdent, Inc. — 1 clearance
- Sybron Endo/Analytic — 1 clearance
- Dentsply Intl. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKR](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EKR)

**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