Cleared Special

K081291 - PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION

K081291 is an FDA 510(k) clearance for PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM..., manufactured by Dentsply Interntional. The device is a Class 2 Dental device with product code DYH cleared through the Special 510(k) pathway after a 15-day FDA review.

K081291 · Dentsply Interntional · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
15d
Days
Class 2
Risk

K081291 is an FDA 510(k) clearance for the PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Dentsply Interntional (York, US). The FDA issued a Cleared decision on May 22, 2008 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 Interntional devices

FDA 510(k) Submission Details - K081291

510(k) Number K081291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2008
Decision Date May 22, 2008
Days to Decision 15 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
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

DYH Device Classification - Class 2, Special Controls

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 135
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K081291.
OPAL SEAL
K090355 · Ultradent Products, Inc. · Apr 2009
FLOWTAIN & FLOWTAIN LV
K083051 · Reliance Orthodontic Products, Inc. · Feb 2009
GC OPB-100
K080724 · GC America, Inc. · Jun 2008
GC MODELS OPA-100 AND JC-50
K073588 · GC America, Inc. · Feb 2008
THERMA-CURE
K071590 · Reliance Orthodontic Products, Inc. · Jul 2007
GRENGLOO
K061481 · Ormco Corp. · Jul 2006