← Product Code [KMY](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY) · K831793 # AQUALIZER MOUTHPIECE (K831793) _Martin D. Lerman · KMY · Aug 12, 1983 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K831793 ## Device Facts - **Applicant:** Martin D. Lerman - **Product Code:** [KMY](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY.md) - **Decision Date:** Aug 12, 1983 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.5525 - **Device Class:** Class 1 - **Review Panel:** Dental ## Regulatory Identification A preformed tooth positioner is a plastic device that is an impression of a perfected bite intended to prevent a patient's teeth from shifting position or to move teeth to a final position after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K831793](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K831793) **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/DE/subpart-f%E2%80%94therapeutic-devices/KMY/K831793