Beach Explorer No. 23T.G.

FDA 510(k) K821780 · Pacific Dental Corp.

Substantially Equivalent

510(k) numberK821780

Submission

Device name
Beach Explorer No. 23T.G.
Applicant
Pacific Dental Corp.
Mchenry, IL, US
Received
June 17, 1982
Decision date
July 6, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EKB – Explorer, Operative
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EKB

510(k)DeviceApplicantDecision
K8517241410/1 to 1435/13 Various Probes & ExplorersEKB · Traditional Artiberia07/02/1985SE
K823914Explorer TipEKB · Traditional Treace Medical, Inc.01/21/1983SE

More from Treace Medical, Inc.

510(k)DeviceDecision
K821782Beach Anesthetic Syringe Cartr. TypeEJI · Traditional 07/20/1982SE
K821790Beach Excavator's No. 1 & No. 2EKD · Traditional 07/06/1982SE
K821789Beach Curette No. 2 and No. 3 T.G.EMS · Traditional 07/06/1982SE
K821788Beach Deriosteal Elevator, #2 StraightEMJ · Traditional 07/06/1982SE
K821787Beach Surgical Pliers Non-HookEJY · Traditional 07/06/1982SE
K821786Beach ScalersEMN · Traditional 07/06/1982SE
K821785Beach Amalgam CarverEKH · Traditional 07/06/1982SE
K821784Beach Gingival Retraction Instr. Type BEIG · Traditional 07/06/1982SE
K821783Beach Silicate Filling & Lining Applic. · Traditional 07/06/1982SE
K821779Beach Amalgam Carrier, Gun TypeEKJ · Traditional 07/06/1982SE

Questions and answers

When was Beach Explorer No. 23T.G. cleared by the FDA?

Beach Explorer No. 23T.G. (K821780) 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 K821780?

The FDA product code is EKB – Explorer, Operative, a Class I (low risk) device regulated under 21 CFR 872.4565.