Bone File, Seldin, #11-TSK Bone File, Double-Ended
FDA 510(k) K884515 · Gatewood and Associates, Ltd.
510(k) numberK884515
Submission
- Device name
- Bone File, Seldin, #11-TSK Bone File, Double-Ended
- Applicant
- Gatewood and Associates, Ltd.
Tacoma, WA, US - Received
- October 27, 1988
- Decision date
- January 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K943351 | Maunal Disposable Dental InstrumentsEKJ · Traditional | Magnum Instruments, Inc. | 10/07/1994SE |
| 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 |
More from Buffalo Dental Mfg. Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K884514 | Forceps, Towel, Backhaus-Tsk (Brand) TowelGEN · Traditional | 11/17/1988SE |
Questions and answers
When was Bone File, Seldin, #11-TSK Bone File, Double-Ended cleared by the FDA?
Bone File, Seldin, #11-TSK Bone File, Double-Ended (K884515) received a 510(k) decision of Substantially Equivalent on January 10, 1989, 75 days after the submission was received.
What is the product code of K884515?
The FDA product code is EKJ – Burnisher, Operative, a Class I (low risk) device regulated under 21 CFR 872.4565.