Cleared Traditional

K780560 - DENTAL AMALGAMATOR (FDA 510(k) Clearance)

K780560 · L.D. Caulk Co. · Dental device

Apr 1978

Decision

16d

Days

Class 1

Risk

K780560 is an FDA 510(k) clearance for the DENTAL AMALGAMATOR. This device is classified as a Amalgamator, Dental, Ac-powered (Class I - General Controls, product code EFD).

Submitted by L.D. Caulk Co. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1978, 16 days after receiving the submission on April 5, 1978.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3100.

Submission Details

510(k) Number	K780560 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 05, 1978
Decision Date	April 21, 1978
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—