Spatula, Dental, Cement
FDA 510(k) K871818 · Military Engineering, Inc.
510(k) numberK871818
Submission
- Device name
- Spatula, Dental, Cement
- Applicant
- Military Engineering, Inc.
Plymouth, IN, US - Received
- May 11, 1987
- Decision date
- July 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140144 | Benda WedgeEJB · Traditional | Centrix, Inc. | 07/08/2014SE |
| K023367 | Detectar, Model N123-MIEJB · Traditional | Neks Technologies | 06/25/2003SE |
| K981234 | Flare,File, FillEJB · Traditional | Lone Star Technologies | 06/05/1998SE |
| K930094 | AukusleeveEJB · Traditional | Aukland Medical Plastics, Inc. | 10/20/1993SE |
| K922633 | Cavi-ZymeEJB · Traditional | E&D Dental Products, Inc. | 08/06/1992SE |
| K833338 | Tooth SloothEJB · Traditional | Joel Lander D.D.S. | 11/25/1983SE |
| K823913 | Soft Grip Uni-HandleEJB · Traditional | Treace Medical, Inc. | 01/26/1983SE |
More from Treace Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874335 | Explorer-Dental ProberEKJ · Traditional | 12/29/1987SE |
| 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 |
| 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 Spatula, Dental, Cement cleared by the FDA?
Spatula, Dental, Cement (K871818) received a 510(k) decision of Substantially Equivalent on July 2, 1987, 52 days after the submission was received.
What is the product code of K871818?
The FDA product code is EJB – Handle, Instrument, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.