FDA 510(k) Premarket Notification K071131: UNO

Submission Details & Decision

Normalized public record details for 510(k) notification K071131.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K071131

Applicant / Sponsor

3M Espe AG Dental Products

Device Name

UNO

Product Code

KLE

Decision Date

2007-07-25

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

2007-04-23

Related Establishments / Registrations

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B.J.M. LABORATORIES LTD Registration: 1000272892 View Registration
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. Registration: 1000625496 View Registration
THE ATLANTA DENTAL SUPPLY COMPANY Registration: 1013257 View Registration
BRASSELER U.S.A. DENTAL, LLC Registration: 1032227 View Registration
BIOMAT SCIENCES, INC. Registration: 1125730 View Registration
PULPDENT CORPORATION Registration: 1215305 View Registration
CENTRIX, INC. Registration: 1281412 View Registration
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BISCO, INC. Registration: 1420052 View Registration
RELIANCE ORTHODONTIC PRODUCTS, INC. Registration: 1420089 View Registration
PRIME DENTAL MANUFACTURING, INC. Registration: 1424442 View Registration
COSMEDENT, INC. Registration: 1450653 View Registration
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DEN-MAT HOLDINGS, LLC Registration: 2018957 View Registration
SCIENTIFIC PHARMACEUTICALS, INC. Registration: 2022039 View Registration
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YOUNG INNOVATIONS INC. Registration: 2024980 View Registration
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J. MORITA USA, INC. Registration: 2081055 View Registration
PAC-DENT INC. Registration: 2086043 View Registration
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INTER-MED, INC. Registration: 2133714 View Registration
PATTERSON DENTAL SUPPLY, INC. Registration: 2183301 View Registration
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PARKELL, INC. Registration: 2411797 View Registration
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