Cleared Traditional

DENTAL NEEDLE PROTECTIVE SYSTEM

K910475 · Health Technology Systems, Inc. · Dental

Sep 1991

Decision

219d

Days

Class 1

Risk

About This 510(k) Submission

K910475 is an FDA 510(k) clearance for the DENTAL NEEDLE PROTECTIVE SYSTEM, a Needle, Dental (Class I — General Controls, product code DZM), submitted by Health Technology Systems, Inc. (Lexington, US). The FDA issued a Cleared decision on September 13, 1991, 219 days after receiving the submission on February 6, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.4730.

Submission Details

510(k) Number	K910475 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 1991
Decision Date	September 13, 1991
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—