Cleared Traditional

STAR/VENT INTERNAL HEX SCREW IMPLANT

K082800 · Park Dental Research Corp. · Dental

Aug 2010

Decision

701d

Days

Class 2

Risk

About This 510(k) Submission

K082800 is an FDA 510(k) clearance for the STAR/VENT INTERNAL HEX SCREW IMPLANT, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Park Dental Research Corp. (Washington, US). The FDA issued a Cleared decision on August 26, 2010, 701 days after receiving the submission on September 24, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K082800 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2008
Decision Date	August 26, 2010
Days to Decision	701 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF