Cleared Traditional

UNO (K071131) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 418
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