Cleared Traditional

K980053 - GLENROE CHAIN
(FDA 510(k) Clearance)

K980053 · Glenroe Technologies · Dental

Feb 1998

Decision

49d

Days

Class 1

Risk

K980053 is an FDA 510(k) clearance for the GLENROE CHAIN. This device is classified as a Band, Elastic, Orthodontic (Class I — General Controls, product code ECI).

Submitted by Glenroe Technologies (Bradenton, US). The FDA issued a Cleared decision on February 24, 1998, 49 days after receiving the submission on January 6, 1998.

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

Submission Details

510(k) Number	K980053 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 1998
Decision Date	February 24, 1998
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement