Cleared Traditional

STAY-PUT IMPREGNATED (K041023) - FDA 510(k) Clearance

K041023 · Coltene/Whaledent GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
56d
Days
-
Risk

K041023 is an FDA 510(k) clearance for the STAY-PUT IMPREGNATED. Classified as Cord, Retraction (product code MVL).

Submitted by Coltene/Whaledent GmbH & Co. KG (New York, US). The FDA issued a Cleared decision on June 15, 2004 after a review of 56 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 Coltene/Whaledent GmbH & Co. KG devices

Submission Details

510(k) Number K041023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2004
Decision Date June 15, 2004
Days to Decision 56 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
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -