Cleared Traditional

MYTIS ARROW XXXX

K052254 · Brainbase Corporation · Dental

Jun 2006

Decision

287d

Days

Class 2

Risk

About This 510(k) Submission

K052254 is an FDA 510(k) clearance for the MYTIS ARROW XXXX, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Brainbase Corporation (Danville, US). The FDA issued a Cleared decision on June 1, 2006, 287 days after receiving the submission on August 18, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number	K052254 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 2005
Decision Date	June 01, 2006
Days to Decision	287 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF