Terumo Dental Needles
FDA 510(k) K864970 · Terumo Medical Corp.
510(k) numberK864970
Submission
- Device name
- Terumo Dental Needles
- Applicant
- Terumo Medical Corp.
Elkton, MD, US - Received
- December 22, 1986
- Decision date
- March 10, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code DZM
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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 |
| 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 |
| K861150 | Exel Dental NeedleDZM · Traditional | Exel Intl. | 04/11/1986SE |
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Questions and answers
When was Terumo Dental Needles cleared by the FDA?
Terumo Dental Needles (K864970) received a 510(k) decision of Substantially Equivalent on March 10, 1987, 78 days after the submission was received.
What is the product code of K864970?
The FDA product code is DZM – Needle, Dental, a Class I (low risk) device regulated under 21 CFR 872.4730.