Cleared Traditional

K922673 - FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING

K922673 is an FDA 510(k) clearance for FLEXIBLE CERAMIC ROPES AND TAPES FOR BO..., manufactured by Glasspan, Inc.. The device is a Class 2 Dental device with product code ELS cleared through the Traditional 510(k) pathway after a 631-day FDA review.

K922673 · Glasspan, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
631d
Days
Class 2
Risk

K922673 is an FDA 510(k) clearance for the FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING. Classified as Splint, Endodontic Stabilizing (product code ELS), Class II - Special Controls.

Submitted by Glasspan, Inc. (Washington, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 631 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3890 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Glasspan, Inc. devices

FDA 510(k) Submission Details - K922673

510(k) Number K922673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
504d slower than avg
Panel avg: 127d · This submission: 631d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELS Device Classification - Class 2, Special Controls

Product Code ELS Splint, Endodontic Stabilizing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.