Cleared Traditional

K083695 - TRAXODENT

K083695 · Premier Dental Products Co. · Dental device
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Apr 2009
Decision
134d
Days
-
Risk

K083695 is an FDA 510(k) clearance for the TRAXODENT. Classified as Cord, Retraction (product code MVL).

Submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on April 28, 2009 after a review of 134 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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FDA 510(k) Submission Details - K083695

510(k) Number K083695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2008
Decision Date April 28, 2009
Days to Decision 134 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
7d slower than avg
Panel avg: 127d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -