Cleared Traditional

HC-BIOS DENTAL IMPLANT

K110425 · Hung Chun Bio-S Co., Ltd. · Dental

Jul 2012

Decision

529d

Days

Class 2

Risk

About This 510(k) Submission

K110425 is an FDA 510(k) clearance for the HC-BIOS DENTAL IMPLANT, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Hung Chun Bio-S Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on July 27, 2012, 529 days after receiving the submission on February 14, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K110425 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 14, 2011
Decision Date	July 27, 2012
Days to Decision	529 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF