Aseptic Dental Tech. Total Treatment System
FDA 510(k) K914562 · Aseptic Dental Technologies, Inc.
510(k) numberK914562
Submission
- Device name
- Aseptic Dental Tech. Total Treatment System
- Applicant
- Aseptic Dental Technologies, Inc.
Arlington Heights, IL, US - Received
- October 15, 1991
- Decision date
- March 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
Questions and answers
When was Aseptic Dental Tech. Total Treatment System cleared by the FDA?
Aseptic Dental Tech. Total Treatment System (K914562) received a 510(k) decision of Substantially Equivalent on March 9, 1992, 146 days after the submission was received.
What is the product code of K914562?
The FDA product code is DZM – Needle, Dental, a Class I (low risk) device regulated under 21 CFR 872.4730.