Beach Excavator's No. 1 & No. 2
FDA 510(k) K821790 · Pacific Dental Corp.
510(k) numberK821790
Submission
- Device name
- Beach Excavator's No. 1 & No. 2
- 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 EKD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K851723 | 1300/10 to 1305/89-92 Various Cutting InstrumentsEKD · Traditional | Artiberia | 07/02/1985SE |
More from Artiberia
| 510(k) | Device | Decision |
|---|---|---|
| K821782 | Beach Anesthetic Syringe Cartr. TypeEJI · Traditional | 07/20/1982SE |
| K821789 | Beach Curette No. 2 and No. 3 T.G.EMS · Traditional | 07/06/1982SE |
| K821788 | Beach Deriosteal Elevator, #2 StraightEMJ · 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 Excavator's No. 1 & No. 2 cleared by the FDA?
Beach Excavator's No. 1 & No. 2 (K821790) 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 K821790?
The FDA product code is EKD – Instrument, Cutting, Operative, a Class I (low risk) device regulated under 21 CFR 872.4565.