Cleared Traditional

K936244 - REGENCY BRACKET
(FDA 510(k) Clearance)

K936244 · Mid-American Dental Specialties, Inc. · Dental device

Feb 1994

Decision

34d

Days

Class 1

Risk

K936244 is an FDA 510(k) clearance for the REGENCY BRACKET. This device is classified as a Bracket, Metal, Orthodontic (Class I - General Controls, product code EJF).

Submitted by Mid-American Dental Specialties, Inc. (Hickory Hills, US). The FDA issued a Cleared decision on February 2, 1994, 34 days after receiving the submission on December 30, 1993.

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

Submission Details

510(k) Number	K936244 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 30, 1993
Decision Date	February 02, 1994
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement