Cleared Traditional

K821782 - BEACH ANESTHETIC SYRINGE CARTR. TYPE
(FDA 510(k) Clearance)

K821782 · Pacific Dental Corp. · Dental

Jul 1982

Decision

33d

Days

Class 2

Risk

K821782 is an FDA 510(k) clearance for the BEACH ANESTHETIC SYRINGE CARTR. TYPE. This device is classified as a Syringe, Cartridge (Class II — Special Controls, product code EJI).

Submitted by Pacific Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1982, 33 days after receiving the submission on June 17, 1982.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.

Submission Details

510(k) Number	K821782 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 1982
Decision Date	July 20, 1982
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—