Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4130](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4130) → DZA — Drill, Dental, Intraoral

# DZA · Drill, Dental, Intraoral

_Dental · 21 CFR 872.4130 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA

## Overview

- **Product Code:** DZA
- **Device Name:** Drill, Dental, Intraoral
- **Regulation:** [21 CFR 872.4130](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4130)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to secure cast or preformed pins to retain operative dental appliances.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K984508](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K984508.md) | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM  AND SURGICAL STRAIGHT HANDPIECES MOD | W&H Dentalwerk Buermoos GmbH | Jun 25, 1999 | SESE |
| [K962979](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K962979.md) | S-53 INTRORAL DENTAL SYSTEM | Del Medical Systems Corp. | Sep 25, 1996 | SESE |
| [K954790](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K954790.md) | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | Tulsa Dental Products, Ltd. | Jan 16, 1996 | SESE |
| [K914724](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K914724.md) | ADA SHANK EXTENSION | Implant Corp. of America | Jul 27, 1993 | SESE |
| [K905418](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K905418.md) | GATES GLIDDEN DRILLS | The Hygenic Corp. | Jul 25, 1991 | SESE |
| [K901097](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K901097.md) | FILLOCK REAMER | Ivoclar North America, Inc. | Apr 25, 1990 | SESE |
| [K896149](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K896149.md) | ANEST-EZE DENTAL DRILL RA#2 | Signature One Products, Inc. | Jan 19, 1990 | SESE |
| [K884187](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K884187.md) | INDENTEC DRILL RA #1 | Phillip C. Crawford, D.D.S. | Dec 22, 1988 | SESE |
| [K811113](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K811113.md) | RIESS-LUHR | Allomedic | Jun 16, 1981 | SESE |
| [K801888](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K801888.md) | HANDPIECE, DENTAL | Aesculap Instruments Corp. | Aug 20, 1980 | SESE |
| [K801887](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K801887.md) | DRILL, DENTAL | Aesculap Instruments Corp. | Aug 20, 1980 | SESE |
| [K761275](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K761275.md) | AIROTOS LF HANDPIECE | Dentsply Intl. | Dec 23, 1976 | SESE |
| [K760956](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA/K760956.md) | SURGICAL MICRO DRILL | American Safety Equipment Corp. | Nov 19, 1976 | SESE |

## Top Applicants

- Aesculap Instruments Corp. — 2 clearances
- Allomedic — 1 clearance
- American Safety Equipment Corp. — 1 clearance
- Del Medical Systems Corp. — 1 clearance
- Dentsply Intl. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZA)

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