Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3740](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3740) → EBL — Pin, Retentive And Splinting, And Accessory Instruments

# EBL · Pin, Retentive And Splinting, And Accessory Instruments

_Dental · 21 CFR 872.3740 · Class 1_

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

## Overview

- **Product Code:** EBL
- **Device Name:** Pin, Retentive And Splinting, And Accessory Instruments
- **Regulation:** [21 CFR 872.3740](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3740)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A retentive and splinting pin is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be placed permanently in a tooth to provide retention and stabilization for a restoration, such as a crown, or to join two or more teeth together.

## 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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K002693](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBL/K002693.md) | CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS) | Cbs Intl. B.V. | Nov 9, 2000 | SESE |
| [K952868](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBL/K952868.md) | DENTAURUM JACKET CROWN & ROOT POSTS | Dentauraum, Inc. | Jul 19, 1995 | SESE |
| [K924376](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBL/K924376.md) | ROOT CANAL POST | The Thera Group | Nov 22, 1993 | SESE |
| [K895283](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBL/K895283.md) | PROSTHETIC RESTORATION DEVICE | Swiss Precision Mfg. Corp. | Feb 14, 1990 | SESE |
| [K895758](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBL/K895758.md) | PLASTIC TOOTH REINFORCEMENT KIT | Nanzee Dental Products | Dec 20, 1989 | SESE |
| [K883074](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBL/K883074.md) | ELGILOY | Dale T. Dupuis | Aug 9, 1988 | SESE |
| [K863831](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBL/K863831.md) | VIVADENT FILPIN | Vivadent (Usa), Inc. | Oct 14, 1986 | SESE |
| [K844457](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBL/K844457.md) | SECURIPIN | Hughes Int'L, Inc. | Dec 27, 1984 | SESE |
| [K830773](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBL/K830773.md) | MARKLEY THREADED WIRE | Almore Intl., Inc. | Apr 28, 1983 | SESE |
| [K822412](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBL/K822412.md) | REINFORCING PIN | Filhol | Aug 30, 1982 | SESE |
| [K760723](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBL/K760723.md) | SAFE-T-PINS RETENTIVE PIN SYSTEM | Parkell, Inc. | Oct 21, 1976 | SESE |

## Top Applicants

- Vivadent (Usa), Inc. — 1 clearance
- The Thera Group — 1 clearance
- Swiss Precision Mfg. Corp. — 1 clearance
- Parkell, Inc. — 1 clearance
- Nanzee Dental Products — 1 clearance

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

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