Cleared Traditional

K902653 - PDS-2000
(FDA 510(k) Clearance)

K902653 · Intl. Equipment and Supply Corp. · Dental device

Sep 1990

Decision

90d

Days

Class 1

Risk

K902653 is an FDA 510(k) clearance for the PDS-2000. This device is classified as a Carver, Wax, Dental (Class I - General Controls, product code EIK).

Submitted by Intl. Equipment and Supply Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 13, 1990, 90 days after receiving the submission on June 15, 1990.

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

Submission Details

510(k) Number	K902653 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 15, 1990
Decision Date	September 13, 1990
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—