Cleared Special

K101546 - ENDOFORM DENTAL TEMPLATE

K101546 · Mesynthes, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
20d
Days
-
Risk

K101546 is an FDA 510(k) clearance for the ENDOFORM DENTAL TEMPLATE. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Mesynthes, Ltd. (North Attleboro, US). The FDA issued a Cleared decision on June 23, 2010 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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.

FDA 510(k) Submission Details - K101546

510(k) Number K101546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2010
Decision Date June 23, 2010
Days to Decision 20 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 115d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

KGN Device Classification - Class 0,

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 188
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K101546 · ENDOFORM DENTAL TEMPLATE
Download PDF FDA Summary Mesynthes, Ltd.