Cleared Traditional

DISPOSABLE PROPHYLAXIS ANGLE

K951016 · Preventive Technologies, Inc. · Dental

May 1995

Decision

57d

Days

Class 1

Risk

About This 510(k) Submission

K951016 is an FDA 510(k) clearance for the DISPOSABLE PROPHYLAXIS ANGLE, a Cup, Prophylaxis (Class I — General Controls, product code EHK), submitted by Preventive Technologies, Inc. (Charlotte, US). The FDA issued a Cleared decision on May 2, 1995, 57 days after receiving the submission on March 6, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.6290.

Submission Details

510(k) Number	K951016 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 06, 1995
Decision Date	May 02, 1995
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF