← Product Code [EHB](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHB) · K921355

# WINGMASTER (K921355)

_Innovators, Inc. · EHB · Sep 25, 1992 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EHB/K921355

## Device Facts

- **Applicant:** Innovators, Inc.
- **Product Code:** [EHB](/submissions/DE/subpart-b%E2%80%94diagnostic-devices/EHB.md)
- **Decision Date:** Sep 25, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.1840
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A dental x-ray position indicating device is a device, such as a collimator, cone, or aperture, that is used in dental radiographic examination. The device is intended to align the examination site with the x-ray beam and to restrict the dimensions of the dental x-ray field by limiting the size of the primary x-ray beam.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EHB/K921355](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/EHB/K921355)

**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