Cleared Traditional

K071131 - UNO

K071131 is an FDA 510(k) clearance for UNO, manufactured by 3M Espe AG Dental Products. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K071131 · 3M Espe AG Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
93d
Days
Class 2
Risk

K071131 is an FDA 510(k) clearance for the UNO. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by 3M Espe AG Dental Products (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on July 25, 2007 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all 3M Espe AG Dental Products devices

FDA 510(k) Submission Details - K071131

510(k) Number K071131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2007
Decision Date July 25, 2007
Days to Decision 93 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
34d faster than avg
Panel avg: 127d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 317
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K071131.
FUTURABOND M/FUTURABOND M SINGLE DOSE
K082753 · Voco GmbH · Nov 2008
G-BOND PLUS
K082768 · GC America, Inc. · Oct 2008
RELIANCE S.E.P.
K071688 · Reliance Orthodontic Products, Inc. · Sep 2007
HERMES BOND 3
K071260 · 3M Espe AG Dental Products · Jul 2007
FL BOND II
K071452 · Shofu Dental Corp. · Jul 2007
FUTURABOND DC/SINGLE DOSE
K070723 · Voco GmbH · Jun 2007