Cleared Traditional

K113617 - SPEE-DEE PATCH

K113617 is the FDA 510(k) clearance for SPEE-DEE PATCH by Pulpdent Corporation. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K113617 · Pulpdent Corporation · Dental device
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Mar 2012
Decision
86d
Days
Class 2
Risk

K113617 is an FDA 510(k) clearance for the SPEE-DEE PATCH. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on March 2, 2012 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pulpdent Corporation devices

Submission Details

510(k) Number K113617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2011
Decision Date March 02, 2012
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 517
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