Cleared Traditional

K082116 - HEMOSTASYL PASTE (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.

View all Satelec devices

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 -

Regulatory Peers - MVL Cord, Retraction

All 35
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K082116.
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VOCO Retraction Paste
K213149 · Voco GmbH · Dec 2021