Cleared Traditional

X O ODONTOSURGE 4

K023672 · Xo Care A/S · Dental

Apr 2003

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K023672 is an FDA 510(k) clearance for the X O ODONTOSURGE 4, a Unit, Electrosurgical, And Accessories, Dental (Class II — Special Controls, product code EKZ), submitted by Xo Care A/S (Lagunga Beach, US). The FDA issued a Cleared decision on April 29, 2003, 179 days after receiving the submission on November 1, 2002. This device falls under the Dental review panel. Regulated under 21 CFR 872.4920.

Submission Details

510(k) Number	K023672 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2002
Decision Date	April 29, 2003
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF