Cleared Traditional

K053329 - KORLEX-GR GINGIVAL RETRACTION PASTE

K053329 · Biotech One, Inc. · Dental device
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Feb 2006
Decision
76d
Days
-
Risk

K053329 is an FDA 510(k) clearance for the KORLEX-GR GINGIVAL RETRACTION PASTE. Classified as Cord, Retraction (product code MVL).

Submitted by Biotech One, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on February 15, 2006 after a review of 76 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.

FDA 510(k) Submission Details - K053329

510(k) Number K053329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2005
Decision Date February 15, 2006
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 128d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

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 K053329.
CORDCAP
K091380 · Centrix, Inc. · Jul 2009
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K083695 · Premier Dental Products Co. · Apr 2009
HEMOSTASYL PASTE
K082116 · Satelec · Dec 2008
EXPA-SYL
K050180 · Produits Dentaires Pierre Rolland · Feb 2005
STAY-PUT IMPREGNATED
K041023 · Coltene/Whaledent GmbH & Co. KG · Jun 2004
ULTRAPAK NEHA
K010070 · Ultradent Products, Inc. · Mar 2001
K053329 · KORLEX-GR GINGIVAL RETRACTION PASTE
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