DZM · Needle, Dental
Dental · 21 CFR 872.4730 · Class 1
Overview
| Product Code | DZM |
|---|---|
| Device Name | Needle, Dental |
| Regulation | 21 CFR 872.4730 |
| Device Class | Class 1 |
| Review Panel | Dental |
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.
Cleared Devices (16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K990511 | X-TIP INTRAOSSEOUS PERFORATOR | Schiff & Co. | Apr 27, 1999 | SESE |
| K920758 | JENKER NEEDLE STICK PROTECTOR | Dentsply Intl. | Apr 28, 1992 | SESE |
| K914562 | ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM | Aseptic Dental Technologies, Inc. | Mar 9, 1992 | SESE |
| K913573 | SAFETY PLUS DENTAL INJECTION NEEDLE | Specialites Septodont | Nov 7, 1991 | SESE |
| K910475 | DENTAL NEEDLE PROTECTIVE SYSTEM | Health Technology Systems, Inc. | Sep 13, 1991 | SESE |
| K910446 | STABIDENT LOCAL ANESTHESIA SYSTEM | Fairfax Dental, Inc. | Jun 3, 1991 | SESE |
| K896219 | SAFE-T-CAP NEEDLE COVER | Ausmedics Pty , Ltd. | Jan 22, 1990 | SESE |
| K894373 | NIPRO DENTAL NEEDLE | Pharma-Plast USA, Inc. | Oct 13, 1989 | SESE |
| K870921 | DENTAL NEEDLE (CARTRIDGE TYPE) | Churchill Corp. | Apr 3, 1987 | SESE |
| K864970 | TERUMO DENTAL NEEDLES | Terumo Medical Corp. | Mar 10, 1987 | SESE |
| K861150 | EXEL DENTAL NEEDLE | Exel Intl. | Apr 11, 1986 | SESE |
| K851524 | SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE | Specialites Septodont | Sep 23, 1985 | SESE |
| K833304 | HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST | Smith & Nephew, Mpl Division | Mar 30, 1984 | SESE |
| K820568 | MUSCLE DYSFUNCTION MONITOR | A Company, Inc. | Apr 9, 1982 | SESE |
| K802811 | MONOJECT ROOT CANAL FILLING MAT. NEEDLE | Sherwood Medical Co. | Nov 24, 1980 | SESE |
| K761206 | INTEROSSEOUS NEEDLE | Smith & Nephew, Mpl Division | Dec 13, 1976 | SESE |
Top Applicants
- Specialites Septodont — 2 clearances
- Smith & Nephew, Mpl Division — 2 clearances
- Terumo Medical Corp. — 1 clearance
- Sherwood Medical Co. — 1 clearance
- Schiff & Co. — 1 clearance
