Cleared Traditional

TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) (K051573) - FDA 510(k) Clearance

Class I Dental device.

K051573 · Dr. Howard Martin, P.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.