Cleared Traditional

K112064 - RESORB X-G (FDA 510(k) Clearance)

K112064 · KLS-Martin L.P. · Dental device

Mar 2012

Decision

248d

Days

Class 2

Risk

K112064 is an FDA 510(k) clearance for the RESORB X-G. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on March 23, 2012, 248 days after receiving the submission on July 19, 2011.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number	K112064 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 19, 2011
Decision Date	March 23, 2012
Days to Decision	248 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF