Cleared Traditional

K010882 - BLUE SKY BIO DENTAL IMPLANT SYSTEM
(FDA 510(k) Clearance)

K010882 · Blue Sky Bio · Dental

Sep 2001

Decision

189d

Days

Class 2

Risk

K010882 is an FDA 510(k) clearance for the BLUE SKY BIO DENTAL IMPLANT SYSTEM, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Blue Sky Bio (Chicago, US). The FDA issued a Cleared decision on September 28, 2001, 189 days after receiving the submission on March 23, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K010882 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 2001
Decision Date	September 28, 2001
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF