Cleared Traditional

KORLEX-GR GINGIVAL RETRACTION PASTE (K053329) - FDA 510(k) Clearance

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.

View all Biotech One, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 127d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 35
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