← Product Code [EBC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC) · K861245

# ORTHOSOURCE ETCH SYSTEMS (K861245)

_Ortho Source · EBC · Apr 11, 1986 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K861245

## Device Facts

- **Applicant:** Ortho Source
- **Product Code:** [EBC](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC.md)
- **Decision Date:** Apr 11, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3765
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K861245](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBC/K861245)

**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