Cleared Special

K102844 - ALL-BOUND 3

K102844 is an FDA 510(k) clearance for ALL-BOUND 3, manufactured by Bisco, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Special 510(k) pathway after a 30-day FDA review.

K102844 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
30d
Days
Class 2
Risk

K102844 is an FDA 510(k) clearance for the ALL-BOUND 3. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on October 29, 2010 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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.

FDA 510(k) Submission Details - K102844

510(k) Number K102844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date October 29, 2010
Days to Decision 30 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
98d faster than avg
Panel avg: 128d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

KLE Device Classification - Class 2, Special Controls

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 414
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K102844.
BEAUTIBOND MULTI
K110235 · Shofu Dental Corp. · May 2011
BEAUTIBOND MULTI PR PLUS
K110252 · Shofu Dental Corp. · May 2011
DMP SINGLE BONDING
K102254 · Dmp, Ltd. · Nov 2010
ALL-ETCH, ALL- ETCH WITH BAC
K101485 · Bisco, Inc. · Aug 2010
OPTIBOND XTR
K101423 · Kerr Corporation · Jul 2010
PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE)
K100752 · Ultradent Products, Inc. · Jul 2010
K102844 · ALL-BOUND 3
Download PDF FDA Summary Bisco, Inc.