Cleared Traditional

K113617 - SPEE-DEE PATCH

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

K113617 · Pulpdent Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K113617

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
Combination Product No
PCCP Authorized No
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.

EBF Device Classification - Class 2, Special Controls

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 784
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K113617.
CLEARFIL MAJESTY FLOW
K121583 · Kuraray Noritake Dental, Inc. · Jul 2012
ES FLOW
K120768 · Spident Co., Ltd. · May 2012
FILTEK BULK FILL FLOWABLE RESTORATIVE
K120453 · 3M Espe Dental Products · Mar 2012
ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A
K112044 · Anaxdent GmbH · Jan 2012
N-HYBRIDE-COMPOSITE LC FLOW
K113444 · Voco GmbH · Dec 2011
N-HYBRIDE-COMPOSITE LC
K113563 · Voco GmbH · Dec 2011