Safety Plus Dental Injection Needle
FDA 510(k) K913573 · Specialites Septodont
510(k) numberK913573
Submission
- Device name
- Safety Plus Dental Injection Needle
- Applicant
- Specialites Septodont
Washington, DC, US - Received
- August 12, 1991
- Decision date
- November 7, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| K990511 | X-Tip Intraosseous PerforatorDZM · Traditional | Schiff & Co. | 04/27/1999SE |
| K920758 | Jenker Needle Stick ProtectorDZM · Traditional | Dentsply Intl. | 04/28/1992SE |
| K914562 | Aseptic Dental Tech. Total Treatment SystemDZM · Traditional | Aseptic Dental Technologies, Inc. | 03/09/1992SE |
| K910475 | Dental Needle Protective SystemDZM · Traditional | Health Technology Systems, Inc. | 09/13/1991SE |
| K910446 | Stabident Local Anesthesia SystemDZM · Traditional | Fairfax Dental, Inc. | 06/03/1991SE |
| K896219 | Safe-T-Cap Needle CoverDZM · Traditional | Ausmedics Pty , Ltd. | 01/22/1990SE |
| K894373 | Nipro Dental NeedleDZM · Traditional | Pharma-Plast USA, Inc. | 10/13/1989SE |
| K870921 | Dental Needle (Cartridge Type)DZM · Traditional | Churchill Corp. | 04/03/1987SE |
| K864970 | Terumo Dental NeedlesDZM · Traditional | Terumo Medical Corp. | 03/10/1987SE |
| K861150 | Exel Dental NeedleDZM · Traditional | Exel Intl. | 04/11/1986SE |
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| K982773 | Quickset Liquid and PowderEMA · Traditional | 11/03/1998SE |
| K982671 | SecuralloyEJJ · Traditional | 10/19/1998SE |
| K980633 | Endosolv EKIF · Traditional | 05/01/1998SE |
| K920692 | Septocalcine UltraEJK · Traditional | 04/21/1992SE |
| K915467 | Cimpat S Dental CementEMA · Traditional | 02/03/1992SE |
| K915466 | Septopack Temporary FillingEBG · Traditional | 02/03/1992SE |
| K913572 | Autopack Non-Eugenol Periodontal DressingEMA · Traditional | 10/09/1991SE |
| K913574 | Septocal Cavity LinerEJK · Traditional | 09/30/1991SE |
Questions and answers
When was Safety Plus Dental Injection Needle cleared by the FDA?
Safety Plus Dental Injection Needle (K913573) received a 510(k) decision of Substantially Equivalent on November 7, 1991, 87 days after the submission was received.
What is the product code of K913573?
The FDA product code is DZM – Needle, Dental, a Class I (low risk) device regulated under 21 CFR 872.4730.