Cleared Traditional

COSP2 (K093721) - FDA 510(k) Clearance

K093721 · 3M Espe AG Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
79d
Days
-
Risk

K093721 is an FDA 510(k) clearance for the COSP2. Classified as Cord, Retraction (product code MVL).

Submitted by 3M Espe AG Dental Products (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on February 19, 2010 after a review of 79 days - a notably fast clearance cycle.

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

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Espe AG Dental Products devices

Submission Details

510(k) Number K093721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2009
Decision Date February 19, 2010
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 35
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K093721.
CyClean Cord
K254239 · SS GLOBAL · Mar 2026
One-Stop
K253797 · Mediclus Co., Ltd. · Feb 2026
Retraxil
K243910 · Kulzer, LLC · Sep 2025
Stasis Gel
K211420 · Belport Company, Inc., Gingi-Pak · Mar 2022
Gingi-Aid Gel
K211419 · Belport Company, Inc., Gingi-Pak · Jan 2022
VOCO Retraction Paste
K213149 · Voco GmbH · Dec 2021