Cleared Traditional

K821788 - BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT
(FDA 510(k) Clearance)

K821788 · Pacific Dental Corp. · Dental device

Jul 1982

Decision

19d

Days

Class 1

Risk

K821788 is an FDA 510(k) clearance for the BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT. This device is classified as a Elevator, Surgical, Dental (Class I - General Controls, product code EMJ).

Submitted by Pacific Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1982, 19 days after receiving the submission on June 17, 1982.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K821788 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 17, 1982
Decision Date	July 06, 1982
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—