Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4760](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4760) → MDL — Implant, Transmandibular

# MDL · Implant, Transmandibular

_Dental · 21 CFR 872.4760 · Class 2_

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

## Overview

- **Product Code:** MDL
- **Device Name:** Implant, Transmandibular
- **Regulation:** [21 CFR 872.4760](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4760)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **Implant:** yes

## Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K900433](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MDL/K900433.md) | SMOOTH STAPLE IMPLANT | Interphase Implants, Inc. | Nov 16, 1990 | SESP |
| [K852894](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/MDL/K852894.md) | ORMCO TRANSMANDIBULAR IMPLANT | Ormco Corp. | Aug 29, 1985 | SESP |

## Top Applicants

- Ormco Corp. — 1 clearance
- Interphase Implants, Inc. — 1 clearance

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

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