X-Tip Intraosseous Perforator
FDA 510(k) K990511 · Schiff & Co.
510(k) numberK990511
Submission
- Device name
- X-Tip Intraosseous Perforator
- Applicant
- Schiff & Co.
West Cadwell, NJ, US - Received
- February 18, 1999
- Decision date
- April 27, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code DZM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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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| K974141 | Plus Reusable ResuscitatorBTM · Traditional | 05/21/1998SE |
| K954448 | Viotec V-2200 Ultraviolet Germicidal Air Purification SystemFRA · Traditional | 10/28/1996SE |
| K955085 | Hm-Cap Eia Test (Modification)LYR · Traditional | 02/09/1996SE |
| K944159 | Hm-Cap Eia KitLYR · Traditional | 07/18/1995SE |
| K943521 | Viotec 1400 Series Ultraviolet Germicidal FixtureFRA · Traditional | 02/14/1995SE |
| K896684 | Kemble Liquid Handling System DispenserJQW · Traditional | 04/16/1990SE |
| K894617 | Olympus Pk-Tp System Reactive ControlGMI · Traditional | 10/31/1989SE |
Questions and answers
When was X-Tip Intraosseous Perforator cleared by the FDA?
X-Tip Intraosseous Perforator (K990511) received a 510(k) decision of Substantially Equivalent on April 27, 1999, 68 days after the submission was received.
What is the product code of K990511?
The FDA product code is DZM – Needle, Dental, a Class I (low risk) device regulated under 21 CFR 872.4730.