Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart E — Surgical Devices](/submissions/DE/subpart-e%E2%80%94surgical-devices) → [21 CFR 872.4730](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4730) → DZM — Needle, Dental

# DZM · Needle, Dental

_Dental · 21 CFR 872.4730 · Class 1_

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

## Overview

- **Product Code:** DZM
- **Device Name:** Needle, Dental
- **Regulation:** [21 CFR 872.4730](/submissions/DE/subpart-e%E2%80%94surgical-devices/872.4730)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A dental injecting needle is a slender, hollow metal device with a sharp point intended to be attached to a syringe to inject local anesthetics and other drugs.

## 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 (16 of 16)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K990511](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K990511.md) | X-TIP INTRAOSSEOUS PERFORATOR | Schiff & Co. | Apr 27, 1999 | SESE |
| [K920758](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K920758.md) | JENKER NEEDLE STICK PROTECTOR | Dentsply Intl. | Apr 28, 1992 | SESE |
| [K914562](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K914562.md) | ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM | Aseptic Dental Technologies, Inc. | Mar 9, 1992 | SESE |
| [K913573](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K913573.md) | SAFETY PLUS DENTAL INJECTION NEEDLE | Specialites Septodont | Nov 7, 1991 | SESE |
| [K910475](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K910475.md) | DENTAL NEEDLE PROTECTIVE SYSTEM | Health Technology Systems, Inc. | Sep 13, 1991 | SESE |
| [K910446](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K910446.md) | STABIDENT LOCAL ANESTHESIA SYSTEM | Fairfax Dental, Inc. | Jun 3, 1991 | SESE |
| [K896219](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K896219.md) | SAFE-T-CAP NEEDLE COVER | Ausmedics Pty , Ltd. | Jan 22, 1990 | SESE |
| [K894373](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K894373.md) | NIPRO DENTAL NEEDLE | Pharma-Plast USA, Inc. | Oct 13, 1989 | SESE |
| [K870921](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K870921.md) | DENTAL NEEDLE (CARTRIDGE TYPE) | Churchill Corp. | Apr 3, 1987 | SESE |
| [K864970](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K864970.md) | TERUMO DENTAL NEEDLES | Terumo Medical Corp. | Mar 10, 1987 | SESE |
| [K861150](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K861150.md) | EXEL DENTAL NEEDLE | Exel Intl. | Apr 11, 1986 | SESE |
| [K851524](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K851524.md) | SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE | Specialites Septodont | Sep 23, 1985 | SESE |
| [K833304](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K833304.md) | HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST | Smith & Nephew, Mpl Division | Mar 30, 1984 | SESE |
| [K820568](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K820568.md) | MUSCLE DYSFUNCTION MONITOR | A Company, Inc. | Apr 9, 1982 | SESE |
| [K802811](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K802811.md) | MONOJECT ROOT CANAL FILLING MAT. NEEDLE | Sherwood Medical Co. | Nov 24, 1980 | SESE |
| [K761206](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/DZM/K761206.md) | INTEROSSEOUS NEEDLE | Smith & Nephew, Mpl Division | Dec 13, 1976 | SESE |

## Top Applicants

- Smith & Nephew, Mpl Division — 2 clearances
- Specialites Septodont — 2 clearances
- A Company, Inc. — 1 clearance
- Aseptic Dental Technologies, Inc. — 1 clearance
- Ausmedics Pty , Ltd. — 1 clearance

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

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