Cleared Traditional

K973495 - GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
(FDA 510(k) Clearance)

K973495 · Glenroe · Dental

Dec 1997

Decision

76d

Days

Class 1

Risk

K973495 is an FDA 510(k) clearance for the GLENROE GLOW IN DARK ELASTOMERIC LIGATURES, a Band, Elastic, Orthodontic (Class I — General Controls, product code ECI), submitted by Glenroe (Bradenton, US). The FDA issued a Cleared decision on December 1, 1997, 76 days after receiving the submission on September 16, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number	K973495 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 1997
Decision Date	December 01, 1997
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement