Cleared Special

PTM SYSTEM (K041335) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041335 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
29d
Days
Class 2
Risk

K041335 is an FDA 510(k) clearance for the PTM SYSTEM. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on June 16, 2004 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dentsply International devices

Submission Details

510(k) Number K041335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2004
Decision Date June 16, 2004
Days to Decision 29 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 127d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

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