← Product Code [MIB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MIB) · K913882 # ZARA SILICONE BLOCK (K913882) _Byron Medical · MIB · Apr 21, 1992 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MIB/K913882 ## Device Facts - **Applicant:** Byron Medical - **Product Code:** [MIB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MIB.md) - **Decision Date:** Apr 21, 1992 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.3620 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat ## Regulatory Identification Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MIB/K913882](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MIB/K913882) **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 as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MIB/K913882