Explorer-Dental Prober
FDA 510(k) K874335 · Military Engineering, Inc.
510(k) numberK874335
Submission
- Device name
- Explorer-Dental Prober
- Applicant
- Military Engineering, Inc.
Plymouth, IN, US - Received
- October 22, 1987
- Decision date
- December 29, 1987
- 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 |
|---|---|---|
| K873715 | Bone Pin Cutter 18HXZ · Traditional | 10/28/1987SE |
| K872842 | Pin, Hip, KnowlesHTY · Traditional | 08/07/1987SE |
| K872091 | Currettes, Alveolar (Molt and Miller)EMS · Traditional | 07/31/1987SE |
| K871834 | Drill, Hand, Bone, SmedbergDZJ · Traditional | 07/31/1987SE |
| K872738 | Cortical Bone ScrewsHWC · Traditional | 07/30/1987SE |
| K872609 | Curette Set, Antrum, CoakleyKAP · Traditional | 07/15/1987SE |
| K871818 | Spatula, Dental, CementEJB · Traditional | 07/02/1987SE |
| K872092 | Osteotome Set, Hoke, Straight, Set of 5KDG · Traditional | 06/23/1987SE |
| K870590 | Curette, Periodontal, Columbia UniversityEMS · Traditional | 04/16/1987SE |
| K871195 | Mallet, Bone Surgery, Stainless Steel, 2LB.HXL · Traditional | 04/06/1987SE |
Questions and answers
When was Explorer-Dental Prober cleared by the FDA?
Explorer-Dental Prober (K874335) received a 510(k) decision of Substantially Equivalent on December 29, 1987, 68 days after the submission was received.
What is the product code of K874335?
The FDA product code is EKJ – Burnisher, Operative, a Class I (low risk) device regulated under 21 CFR 872.4565.