Maunal Disposable Dental Instruments
FDA 510(k) K943351 · Magnum Instruments, Inc.
510(k) numberK943351
Submission
- Device name
- Maunal Disposable Dental Instruments
- Applicant
- Magnum Instruments, Inc.
Glendale Heights, IL, US - Received
- July 12, 1994
- Decision date
- October 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EKJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961714 | Aseptylum, Uni-CarrierEKJ · Traditional | Distriflor S.A. | 06/10/1996SE |
| K953707 | Medtrol Dental KitEKJ · Traditional | Medtrol, Inc. | 01/04/1996SE |
| K945815 | Dental KitEKJ · Traditional | Constancy Ent., Inc. | 07/19/1995SE |
| K951607 | Sureflex FilesEKJ · Traditional | Dentsply Intl. | 06/22/1995SE |
| K945077 | Instrument,Filling,Plastic,DentalEKJ · Traditional | Worldwide Dental, Inc. | 11/30/1994SE |
| K943820 | Stat PakEKJ · Traditional | Magnum Instruments, Inc. | 11/02/1994SE |
| K943584 | Presterilized Endodontic FilesEKJ · Traditional | Dentsply Intl. | 09/21/1994SE |
| K935127 | Southland Sterile Dental SystemEKJ · Traditional | Southland, Ltd. | 07/28/1994SE |
| K941954 | Non-Fogging Dental MirrorEKJ · Traditional | Buffalo Dental Mfg. Co., Inc. | 07/08/1994SE |
| K925115 | Amd Dentist and Hygienist KitsEKJ · Traditional | Advance Medical Designs, Inc. | 07/05/1994SE |
More from Advance Medical Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943820 | Stat PakEKJ · Traditional | 11/02/1994SE |
Questions and answers
When was Maunal Disposable Dental Instruments cleared by the FDA?
Maunal Disposable Dental Instruments (K943351) received a 510(k) decision of Substantially Equivalent on October 7, 1994, 87 days after the submission was received.
What is the product code of K943351?
The FDA product code is EKJ – Burnisher, Operative, a Class I (low risk) device regulated under 21 CFR 872.4565.