Cleared Traditional

HEMOSTASYL PASTE (K082116) - FDA 510(k) Clearance

K082116 · Satelec · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
142d
Days
-
Risk

K082116 is an FDA 510(k) clearance for the HEMOSTASYL PASTE. Classified as Cord, Retraction (product code MVL).

Submitted by Satelec (Mt. Laurel, US). The FDA issued a Cleared decision on December 17, 2008 after a review of 142 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K082116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2008
Decision Date December 17, 2008
Days to Decision 142 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
15d slower than avg
Panel avg: 127d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -