Cleared Traditional

FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING

K922673 · Glasspan, Inc. · Dental

Feb 1994

Decision

631d

Days

Class 2

Risk

About This 510(k) Submission

K922673 is an FDA 510(k) clearance for the FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING, a Splint, Endodontic Stabilizing (Class II — Special Controls, product code ELS), submitted by Glasspan, Inc. (Washington, Dc, US). The FDA issued a Cleared decision on February 25, 1994, 631 days after receiving the submission on June 4, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.3890.

Submission Details

510(k) Number	K922673 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 1992
Decision Date	February 25, 1994
Days to Decision	631 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF