Cleared Traditional

K954990 - DENTAL DAM
(FDA 510(k) Clearance)

K954990 · The Hygenic Corp. · Dental device

Jan 1996

Decision

87d

Days

Class 1

Risk

K954990 is an FDA 510(k) clearance for the DENTAL DAM. This device is classified as a Dam, Rubber (Class I - General Controls, product code EIE).

Submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on January 26, 1996, 87 days after receiving the submission on October 31, 1995.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number	K954990 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 31, 1995
Decision Date	January 26, 1996
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement