Cleared Traditional

K082116 - HEMOSTASYL PASTE

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

FDA 510(k) Submission Details - K082116

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
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 128d · This submission: 142d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 34
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K082116.
LIQUICORD
K092384 · Centrix, Inc. · Nov 2009
CORDCAP
K091380 · Centrix, Inc. · Jul 2009
TRAXODENT
K083695 · Premier Dental Products Co. · Apr 2009
KORLEX-GR GINGIVAL RETRACTION PASTE
K053329 · Biotech One, Inc. · Feb 2006
EXPA-SYL
K050180 · Produits Dentaires Pierre Rolland · Feb 2005
ULTRAPAK NEHA
K010070 · Ultradent Products, Inc. · Mar 2001