Cleared Traditional

K925064 - RELAX-O-GUARD
(FDA 510(k) Clearance)

K925064 · Aquatemp Service Co., Inc. · Dental

Sep 1993

Decision

342d

Days

Class 1

Risk

K925064 is an FDA 510(k) clearance for the RELAX-O-GUARD, a Positioner, Tooth, Preformed (Class I — General Controls, product code KMY), submitted by Aquatemp Service Co., Inc. (Morristown, US). The FDA issued a Cleared decision on September 13, 1993, 342 days after receiving the submission on October 6, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.5525.

Submission Details

510(k) Number	K925064 FDA.gov
FDA Decision	Cleared SN
Date Received	October 06, 1992
Decision Date	September 13, 1993
Days to Decision	342 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—