← Product Code [FWP](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP) · K913761

# 3-D ACCUSCAN FACIAL IMPLANTS (K913761)

_Implantech Associates, Inc. · FWP · Oct 17, 1991 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K913761

## Device Facts

- **Applicant:** Implantech Associates, Inc.
- **Product Code:** [FWP](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP.md)
- **Decision Date:** Oct 17, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.3550
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K913761](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/FWP/K913761)

**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
