← Back to catalogue

Uno

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071131

by 3M Espe AG Dental Products

Identifiers

510(k) Number
K071131 FDA 510(k)
FDA Product Code
KLE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3200 FDA 510(k)
Regulation Number
872.3200 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Uno is a resin tooth bonding agent used in dental procedures. It functions as a dental adhesive to facilitate the bonding of restorative materials to tooth structure.

This device is classified as a Class II medical device under regulation number 872.3200. It received FDA 510(k) clearance on July 25, 2007, under the product code KLE.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K071131 FDA 510 (k) - UNO | 3M Espe AG Dental Products, All 3M Products for Dental | 3M United States, Dental solutions | Solventum

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
3M Espe AG Dental Products

Sources (1)

  • FDA 510(k) K071131 24 fields · synced Oct 6, 2026