Nipro Dental Needle
FDA 510(k) K894373 · Pharma-Plast USA, Inc.
510(k) numberK894373
Submission
- Device name
- Nipro Dental Needle
- Applicant
- Pharma-Plast USA, Inc.
Clearwater, FL, US - Received
- July 17, 1989
- Decision date
- October 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code DZM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K913573 | Safety Plus Dental Injection NeedleDZM · Traditional | Specialites Septodont | 11/07/1991SE |
| 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 |
| 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 |
More from Exel Intl.
| 510(k) | Device | Decision |
|---|---|---|
| K894371 | Nipro Safelet CathFOZ · Traditional | 10/25/1989SE |
| K894374 | Blood Drawing NeedleFMI · Traditional | 09/28/1989SE |
| K894372 | Nipro Needle HolderFMI · Traditional | 09/28/1989SE |
| K884978 | Pharma-Plast Insulin Infusion SetLZG · Traditional | 06/21/1989SE |
| K871263 | Multiple Pharma-Plast Tracheal TubeBTR · Traditional | 06/15/1987SE |
| K852444 | Asik 'Once' SyringeFMF · Traditional | 10/16/1985SE |
| K852443 | Pharma-Plast ClinipakFMF · Traditional | 10/16/1985SE |
| K852442 | Pharma-Plast NeedleFMI · Traditional | 09/20/1985SE |
Questions and answers
When was Nipro Dental Needle cleared by the FDA?
Nipro Dental Needle (K894373) received a 510(k) decision of Substantially Equivalent on October 13, 1989, 88 days after the submission was received.
What is the product code of K894373?
The FDA product code is DZM – Needle, Dental, a Class I (low risk) device regulated under 21 CFR 872.4730.