Tactile Plus Dental Elevators
FDA 510(k) K850906 · Ipco Corp.
510(k) numberK850906
Submission
- Device name
- Tactile Plus Dental Elevators
- Applicant
- Ipco Corp.
White Plains, NY, US - Received
- March 5, 1985
- Decision date
- April 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EMJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870589 | Elevator, Root, Single-EndedEMJ · Traditional | Military Engineering, Inc. | 04/03/1987SE |
| K851717 | 880/1 to 890/4 Various Types of Perioteal ElevatorEMJ · Traditional | Artiberia | 06/14/1985SE |
| K851713 | 680/1 to 785/2 Various Types & Sizes of Root ElevaEMJ · Traditional | Artiberia | 06/11/1985SE |
| K821788 | Beach Deriosteal Elevator, #2 StraightEMJ · Traditional | Pacific Dental Corp. | 07/06/1982SE |
| K771747 | Periosteal ElevatorEMJ · Traditional | Depuy, Inc. | 09/28/1977SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871270 | Perform Denture Base ResinEBF · Traditional | 05/29/1987SE |
| K850666 | Strobex Ultron Electrosurge-Dental UnitEKZ · Traditional | 05/29/1985SE |
| K842837 | Safe & Soft Maxi ShiledsHHD · Traditional | 10/15/1984SE |
| K842836 | Safe & Soft Mini Pads & Maxi PadsHHD · Traditional | 10/15/1984SE |
| K842838 | Safe & Soft Panty ShieldsHHD · Traditional | 10/05/1984SE |
| K841953 | Ultra Shield BriefsEYQ · Traditional | 07/19/1984SE |
| K840755 | Minigard Disposable LinersEYQ · Traditional | 04/13/1984SE |
| K840754 | Maxishield Incontinence Care SystemEYQ · Traditional | 04/13/1984SE |
| K840753 | Ambeze Disposable Incontinence PantsEYQ · Traditional | 04/13/1984SE |
| K800293 | File, Pulp CanalEKS · Traditional | 02/19/1980SE |
Questions and answers
When was Tactile Plus Dental Elevators cleared by the FDA?
Tactile Plus Dental Elevators (K850906) received a 510(k) decision of Substantially Equivalent on April 12, 1985, 38 days after the submission was received.
What is the product code of K850906?
The FDA product code is EMJ – Elevator, Surgical, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.