Beach Gingival Retraction Instr. Type B
FDA 510(k) K821784 · Pacific Dental Corp.
510(k) numberK821784
Submission
- Device name
- Beach Gingival Retraction Instr. Type B
- 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 EIG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971284 | OpaldamEIG · Traditional | Ultradent Products, Inc. | 06/03/1997SE |
| K854711 | Fibrelight Illuminating Oral RetractorsEIG · Traditional | Downs Surgical , Ltd. | 02/25/1986SE |
| K832366 | Zoller Burned Lip ConformerEIG · Traditional | Universal Prosthetics, Inc. | 09/26/1983SE |
| K771973 | GingitractEIG · Traditional | Den-Mat Corp. | 11/07/1977SE |
| K771399 | Lip & Cheek RetractorEIG · Traditional | L.D. Caulk Co. | 08/26/1977SE |
| K761024 | Racestyptine RingsEIG · Traditional | Septodont, Inc. | 11/19/1976SE |
| K760657 | Racestyptine CordEIG · Traditional | Septodont, Inc. | 09/27/1976SE |
More from Septodont, 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 |
| 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 |
| 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 Gingival Retraction Instr. Type B cleared by the FDA?
Beach Gingival Retraction Instr. Type B (K821784) 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 K821784?
The FDA product code is EIG – Retractor, All Types, a Class I (low risk) device regulated under 21 CFR 872.4565.