Cleared Traditional

K051573 - TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)

K051573 is an FDA 510(k) clearance for TGP (GUTTA PERCHA CONTAINING TETRACYCLI..., manufactured by Dr. Howard Martin, P.A.. The device is a Class 1 Dental device with product code EKM cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K051573 · Dr. Howard Martin, P.A. · Dental device
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Jun 2006
Decision
377d
Days
Class 1
Risk

K051573 is an FDA 510(k) clearance for the TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE). Classified as Gutta-percha (product code EKM), Class I - General Controls.

Submitted by Dr. Howard Martin, P.A. (Frederick, US). The FDA issued a Cleared decision on June 26, 2006 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3850 - the FDA dental device regulatory framework. 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. Elevated predicate reliance profile. 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 Dr. Howard Martin, P.A. devices

FDA 510(k) Submission Details - K051573

510(k) Number K051573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2005
Decision Date June 26, 2006
Days to Decision 377 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
250d slower than avg
Panel avg: 127d · This submission: 377d
Pathway characteristics
Predicate-based equivalence.

EKM Device Classification - Class 1, General Controls

Product Code EKM Gutta-percha
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3850
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.