← Product Code [ELE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE) · K843557

# K-APATITE 20-40 MESH K-APATITE 40-60 (K843557)

_Katecho, Inc. · ELE · Nov 30, 1984 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE/K843557

## Device Facts

- **Applicant:** Katecho, Inc.
- **Product Code:** [ELE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE.md)
- **Decision Date:** Nov 30, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3645
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE/K843557](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELE/K843557)

**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