Cleared Traditional

K935154 - DENTAURUM EXPANSION SCREWS
(FDA 510(k) Clearance)

K935154 · Dentauraum, Inc. · Dental device

Feb 1994

Decision

98d

Days

Class 1

Risk

K935154 is an FDA 510(k) clearance for the DENTAURUM EXPANSION SCREWS. This device is classified as a Retainer, Screw Expansion, Orthodontic (Class I - General Controls, product code DYJ).

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on February 3, 1994, 98 days after receiving the submission on October 28, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number	K935154 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 28, 1993
Decision Date	February 03, 1994
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement