Cleared Special

K050959 - DELTON ILLUMINATING PIT AND FISSURE SEALING

K050959 is an FDA 510(k) clearance for DELTON ILLUMINATING PIT AND FISSURE SEALING, manufactured by Dentsply International. The device is a Class 2 Dental device with product code EBC cleared through the Special 510(k) pathway after a 23-day FDA review.

K050959 · Dentsply International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
23d
Days
Class 2
Risk

K050959 is an FDA 510(k) clearance for the DELTON ILLUMINATING PIT AND FISSURE SEALING. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Dentsply International (York, US). The FDA issued a Cleared decision on May 11, 2005 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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

FDA 510(k) Submission Details - K050959

510(k) Number K050959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2005
Decision Date May 11, 2005
Days to Decision 23 days
Submission Type Special
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
104d faster than avg
Panel avg: 127d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 85
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K050959.
EMBRACE WETBOND CLEAR SEALANT
K052281 · Pulpdent Corporation · Feb 2006
ASCENT PIT & FISSURE SEALANT
K053089 · CAO Group, Inc. · Dec 2005
BOSWORTH SEAL
K051224 · Harry J. Bosworth Co. · Jul 2005
COSMEDENT PIT & FISSURE SEALANT
K042823 · Cosmedent, Inc. · Dec 2004
AEGIS PIT & FISSURE SEALANT WITH ACP
K033751 · Harry J. Bosworth Co. · Feb 2004
PIT & FISSURE SEALANT WITH FLUORIDE
K031811 · Harry J. Bosworth Co. · Sep 2003