Needle, Dental
The Dental Needle is a sterile, single-use device used by dental professionals to deliver local anesthetic agents into intraoral tissues for pain control during dental procedures. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is DZM and the applicable regulation is 21 CFR 872.4730, under the Dental medical specialty.
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Basic Information
- Product Code
- DZM
- Device Class
- FDA class 1
- Regulation Number
- 872.4730
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K990511 | X-TIP INTRAOSSEOUS PERFORATOR | Apr 27, 1999 | Substantially Equivalent | Schiff & Co. |
| K920758 | JENKER NEEDLE STICK PROTECTOR | Apr 28, 1992 | Substantially Equivalent | Dentsply Intl. |
| K914562 | ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM | Mar 09, 1992 | Substantially Equivalent | Aseptic Dental Technologies, Inc. |
| K913573 | SAFETY PLUS DENTAL INJECTION NEEDLE | Nov 07, 1991 | Substantially Equivalent | Specialites Septodont |
| K910475 | DENTAL NEEDLE PROTECTIVE SYSTEM | Sep 13, 1991 | Substantially Equivalent | Health Technology Systems, Inc. |
| K910446 | STABIDENT LOCAL ANESTHESIA SYSTEM | Jun 03, 1991 | Substantially Equivalent | Fairfax Dental, Inc. |
| K896219 | SAFE-T-CAP NEEDLE COVER | Jan 22, 1990 | Substantially Equivalent | Ausmedics Pty , Ltd. |
| K894373 | NIPRO DENTAL NEEDLE | Oct 13, 1989 | Substantially Equivalent | Pharma-Plast USA, Inc. |
| K870921 | DENTAL NEEDLE (CARTRIDGE TYPE) | Apr 03, 1987 | Substantially Equivalent | Churchill Corp. |
| K864970 | TERUMO DENTAL NEEDLES | Mar 10, 1987 | Substantially Equivalent | Terumo Medical Corp. |
| K861150 | EXEL DENTAL NEEDLE | Apr 11, 1986 | Substantially Equivalent | Exel Intl. |
| K851524 | SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE | Sep 23, 1985 | Substantially Equivalent | Specialites Septodont |
| K833304 | HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST | Mar 30, 1984 | Substantially Equivalent | Smith & Nephew, Mpl Division |
| K820568 | MUSCLE DYSFUNCTION MONITOR | Apr 09, 1982 | Substantially Equivalent | A Company, Inc. |
| K802811 | MONOJECT ROOT CANAL FILLING MAT. NEEDLE | Nov 24, 1980 | Substantially Equivalent | Sherwood Medical Co. |
| K761206 | INTEROSSEOUS NEEDLE | Dec 13, 1976 | Substantially Equivalent | Smith & Nephew, Mpl Division |
FEI Numbers
This FDA classification entry is associated with 147 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 147 registration numbers. Click on an entry to view related FDA registrations.