Cleared Traditional

K936243 - REGENCY TUBE
(FDA 510(k) Clearance)

K936243 · Ortho Specialties · Dental device

Feb 1994

Decision

34d

Days

Class 1

Risk

K936243 is an FDA 510(k) clearance for the REGENCY TUBE. This device is classified as a Tube, Orthodontic (Class I - General Controls, product code DZD).

Submitted by Ortho Specialties (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	K936243 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