Beach Deriosteal Elevator, #2 Straight
FDA 510(k) K821788 · Pacific Dental Corp.
510(k) numberK821788
Submission
- Device name
- Beach Deriosteal Elevator, #2 Straight
- Applicant
- Pacific Dental Corp.
Mchenry, IL, US - Received
- June 17, 1982
- Decision date
- July 6, 1982
- 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 |
| K850906 | Tactile Plus Dental ElevatorsEMJ · Traditional | Ipco Corp. | 04/12/1985SE |
| K771747 | Periosteal ElevatorEMJ · Traditional | Depuy, Inc. | 09/28/1977SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821782 | Beach Anesthetic Syringe Cartr. TypeEJI · Traditional | 07/20/1982SE |
| K821790 | Beach Excavator's No. 1 & No. 2EKD · Traditional | 07/06/1982SE |
| K821789 | Beach Curette No. 2 and No. 3 T.G.EMS · Traditional | 07/06/1982SE |
| K821787 | Beach Surgical Pliers Non-HookEJY · Traditional | 07/06/1982SE |
| K821786 | Beach ScalersEMN · Traditional | 07/06/1982SE |
| K821785 | Beach Amalgam CarverEKH · Traditional | 07/06/1982SE |
| K821784 | Beach Gingival Retraction Instr. Type BEIG · Traditional | 07/06/1982SE |
| K821783 | Beach Silicate Filling & Lining Applic. · Traditional | 07/06/1982SE |
| K821780 | Beach Explorer No. 23T.G.EKB · Traditional | 07/06/1982SE |
| K821779 | Beach Amalgam Carrier, Gun TypeEKJ · Traditional | 07/06/1982SE |
Questions and answers
When was Beach Deriosteal Elevator, #2 Straight cleared by the FDA?
Beach Deriosteal Elevator, #2 Straight (K821788) received a 510(k) decision of Substantially Equivalent on July 6, 1982, 19 days after the submission was received.
What is the product code of K821788?
The FDA product code is EMJ – Elevator, Surgical, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.