Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3645](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3645) → ELE — Implant, Subperiosteal

# ELE · Implant, Subperiosteal

_Dental · 21 CFR 872.3645 · Class 2_

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

## Overview

- **Product Code:** ELE
- **Device Name:** Implant, Subperiosteal
- **Regulation:** [21 CFR 872.3645](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3645)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **Implant:** yes

## Identification

Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum intended to construct custom prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for prostheses, such as dentures.

## Classification Rationale

Class II.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K210228](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE/K210228.md) | KLS Martin IPS Preprosthetic | KLS-Martin L.P. | Jul 8, 2022 | SESE |
| [K862926](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE/K862926.md) | SURGICAL VITEX | Jeneric Ind. | Aug 29, 1986 | SESE |
| [K843557](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE/K843557.md) | K-APATITE 20-40 MESH K-APATITE 40-60 | Katecho, Inc. | Nov 30, 1984 | SESE |
| [K801208](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE/K801208.md) | HOLLOW BASKET TITANIUM DENTAL IMPLANT | Colmed, Ltd. | May 28, 1980 | SESE |

## Top Applicants

- Colmed, Ltd. — 1 clearance
- Jeneric Ind. — 1 clearance
- KLS-Martin L.P. — 1 clearance
- Katecho, Inc. — 1 clearance

---

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

**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