Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4535](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4535) → DZP — Instrument, Diamond, Dental # DZP · Instrument, Diamond, Dental _Dental · 21 CFR 872.4535 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP ## Overview - **Product Code:** DZP - **Device Name:** Instrument, Diamond, Dental - **Regulation:** [21 CFR 872.4535](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4535) - **Device Class:** 1 - **Review Panel:** [Dental](/submissions/DE) ## Identification A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation of the diamond instrument provides an abrasive action when it contacts a tooth. ## Classification Rationale Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. ## Recent Cleared Devices (20 of 21) Showing 20 most recent of 21 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K120037](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K120037.md) | BLUWHITE DIAMOND DENTAL BURS MODIFIED | Beavers Dental, Div. Sybron Canada, Ltd. | Apr 20, 2012 | SESE | | [K943841](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K943841.md) | SOPHOS DENTAL DIAMOND | Sophos Technologic | Sep 16, 1994 | SESE | | [K940908](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K940908.md) | DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS | Dunhall Pharmaceuticals, Inc. | Aug 29, 1994 | SESE | | [K934981](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K934981.md) | DENTAL DRILL | Eare Consulting Service | Feb 3, 1994 | SESE | | [K923757](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K923757.md) | DENTAL DIAMOND DRILLS | Alpha Industrializacao DE Metais Ltda. | Mar 16, 1993 | SESE | | [K913651](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K913651.md) | MANI DIA-BURS | The Lahr Consulting Group, Inc. | Jan 14, 1992 | SESE | | [K901967](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K901967.md) | DENDIA WERK BURS AND CUTTING DISCS | Micro-Aire Surgical Instruments, Inc. | Jul 13, 1990 | SESE | | [K901262](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K901262.md) | F.G. LASER (DENTAL BUR) | Diamond Rotary and Carbide Intl. | Jul 9, 1990 | SESE | | [K900089](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K900089.md) | FG DIAMOND BURRS | Kab Gloves Unltd. | Apr 3, 1990 | SESE | | [K893844](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K893844.md) | 3D DENTAL DIAMOND ROTARY INSTRUMENTS | Lustgarten Multi-Tech International, Inc. | Aug 11, 1989 | SESE | | [K885233](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K885233.md) | NOVA DIAMOND | Microcopy, Div. Neo-Flo, Inc. | Feb 13, 1989 | SESE | | [K880179](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K880179.md) | BEAVERS' DENTAL DIAMOND INSTRUMENTS | Beavers Dental, Div. Sybron Canada, Ltd. | Mar 9, 1988 | SESE | | [K871639](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K871639.md) | DENTAL DIAMOND BURS | E&D Dental Manufacturing Co. | May 18, 1987 | SESE | | [K854347](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K854347.md) | HYBRID POINTS | Shofu Dental Corp. | Dec 27, 1985 | SESE | | [K833038](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K833038.md) | SUMMA DISK | Shofu Dental Corp. | Oct 4, 1983 | SESE | | [K832856](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K832856.md) | GINGI CURETTAGE DIAMOND POINTS | Shofu Dental Corp. | Oct 4, 1983 | SESE | | [K832855](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K832855.md) | TPE DIAMOND POINTS | Shofu Dental Corp. | Sep 29, 1983 | SESE | | [K802987](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K802987.md) | JOTA DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. | Dec 30, 1980 | SESE | | [K802984](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K802984.md) | MEISINGER DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. | Dec 30, 1980 | SESE | | [K780864](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP/K780864.md) | DIAMOND STONES | Venture Technology, Inc. | Jun 14, 1978 | SESE | ## Top Applicants - Shofu Dental Corp. — 4 clearances - Beavers Dental, Div. Sybron Canada, Ltd. — 2 clearances - Swiss American Metal Craft Corp. — 2 clearances - Adp Intl., Inc. — 1 clearance - Alpha Industrializacao DE Metais Ltda. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZP) **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