Cleared Traditional

K051751 - EQUA-PULL SAFETY RELEASE MODULE
(FDA 510(k) Clearance)

K051751 · Ortho Technology · Dental

Jul 2005

Decision

23d

Days

Class 2

Risk

K051751 is an FDA 510(k) clearance for the EQUA-PULL SAFETY RELEASE MODULE. This device is classified as a Headgear, Extraoral, Orthodontic (Class II — Special Controls, product code DZB).

Submitted by Ortho Technology (Tampa, US). The FDA issued a Cleared decision on July 22, 2005, 23 days after receiving the submission on June 29, 2005.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5500.

Submission Details

510(k) Number	K051751 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2005
Decision Date	July 22, 2005
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement