Cleared Traditional

K905461 - PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (FDA 510(k) Clearance)

K905461 · Angiosystems, Inc. · Dental device

Mar 1991

Decision

90d

Days

Class 1

Risk

K905461 is an FDA 510(k) clearance for the PROCEDURE KIT/ROUTINE DENTAL PROCEDURES. This device is classified as a File, Pulp Canal, Endodontic (Class I - General Controls, product code EKS).

Submitted by Angiosystems, Inc. (Great Neck, US). The FDA issued a Cleared decision on March 5, 1991, 90 days after receiving the submission on December 5, 1990.

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

Submission Details

510(k) Number	K905461 FDA.gov
FDA Decision	Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received	December 05, 1990
Decision Date	March 05, 1991
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—