← Product Code [DZJ](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ) · K943540 # SURGICAL CUTTING BURS (K943540) _Stryker Corp. · DZJ · Nov 30, 1994 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K943540 ## Device Facts - **Applicant:** Stryker Corp. - **Product Code:** [DZJ](/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ.md) - **Decision Date:** Nov 30, 1994 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4120 - **Device Class:** Class 2 - **Review Panel:** Dental ## Regulatory Identification A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K943540](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZJ/K943540) **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-e%E2%80%94surgical-devices/DZJ/K943540