Beach Scalers
FDA 510(k) K821786 · Pacific Dental Corp.
510(k) numberK821786
Submission
- Device name
- Beach Scalers
- 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 EMN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070127 | Plaque Scraper-A Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02EMN · Traditional | Kevin Vu, Dds | 03/29/2007SE |
| K931330 | Dental Instruments ScalerEMN · Traditional | Minnesota Prophy Power, Inc. | 01/26/1994SE |
| K851721 | 1200/1 to 1240/15 Various Types of Dental ScalersEMN · Traditional | Artiberia | 07/02/1985SE |
| K781035 | Periodontal Instrument #21 Goldman-FoxEMN · Traditional | Premier Dental Products Co. | 06/30/1978SE |
More from Premier Dental Products Co.
| 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 |
| 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 Scalers cleared by the FDA?
Beach Scalers (K821786) 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 K821786?
The FDA product code is EMN – Scaler, Periodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.