FDA 510(k) Premarket Notification K110302: ADHESIVE EXL-759

Submission Details & Decision

Normalized public record details for 510(k) notification K110302.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K110302

Applicant / Sponsor

3M Espe AG

Device Name

ADHESIVE EXL-759

Product Code

KLE

Decision Date

2011-05-19

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

2011-02-02

Related Establishments / Registrations

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. Registration: 1000118628 View Registration
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
GC AMERICA INC. Registration: 1410097 View Registration
BEUTLICH PHARMACEUTICALS, LLC Registration: 1413399 View Registration
DENTAL TECHNOLOGIES, INC. Registration: 1413475 View Registration
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
RMO Registration: 1718476 View Registration
Ultradent Products Inc. Registration: 1718912 View Registration
CAO GROUP, INC. Registration: 1725006 View Registration
TP ORTHODONTICS, INC. Registration: 1815540 View Registration
The Belport Company, Inc DBA Gingi-Pak Registration: 2014676 View Registration
DEN-MAT HOLDINGS, LLC Registration: 2018957 View Registration
SCIENTIFIC PHARMACEUTICALS, INC. Registration: 2022039 View Registration
ZEST ANCHORS, LLC Registration: 2023950 View Registration
Kerr Corporation Registration: 2024312 View Registration
YOUNG INNOVATIONS INC. Registration: 2024980 View Registration
DENT ZAR, INC. Registration: 2027375 View Registration
J. MORITA USA, INC. Registration: 2081055 View Registration
PAC-DENT INC. Registration: 2086043 View Registration
AMERICAN ORTHODONTICS Registration: 2126683 View Registration
INTER-MED, INC. Registration: 2133714 View Registration
PATTERSON DENTAL SUPPLY, INC. Registration: 2183301 View Registration
DMG America LLC Registration: 2244812 View Registration
Ivoclar Vivadent Manufacturing, Inc Registration: 2244842 View Registration
PARKELL, INC. Registration: 2411797 View Registration
DENTSPLY LLC Registration: 2424472 View Registration
TEMREX CORP. Registration: 2429849 View Registration
ESSENTIAL DENTAL SYSTEMS, INC. Registration: 2433629 View Registration
CARGUS INT'L, INC. Registration: 2437780 View Registration
PREMIER DENTAL PRODUCTS CO. Registration: 2511556 View Registration
DENTSPLY LLC Registration: 2515379 View Registration
Keystone Industries Registration: 2523320 View Registration
SHOFU DENTAL CORP. Registration: 2916735 View Registration
Patterson Dental Canada Inc. Registration: 3000219976 View Registration
DELTAMED GMBH Registration: 3002789526 View Registration
GC CORPORATION-FUJI OYAMA FACTORY Registration: 3002807050 View Registration
KURARAY NORITAKE DENTAL NIIGATA PLANT Registration: 3002807420 View Registration
SHOFU INC. Registration: 3002808149 View Registration
KASH SALES INC. Registration: 3003120666 View Registration
VERICOM CO., LTD. Registration: 3003449480 View Registration
TOKUYAMA DENTAL CORPORATION Kashima Factory Registration: 3003621174 View Registration
SDI LTD. Registration: 3004140838 View Registration
PREMIUM PLUS DENTAL SUPPLIES INC Registration: 3004425647 View Registration
CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITED Registration: 3004475754 View Registration
Ivoclar Vivadent GmbH Registration: 3004966444 View Registration
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. Registration: 3005176727 View Registration
PREVEST DENPRO LIMITED Registration: 3005628474 View Registration
KULZER GMBH Registration: 3005665377 View Registration
Klema Dentalprodukte GMBH Registration: 3005974404 View Registration
SPIDENT CO., LTD. Registration: 3006113314 View Registration
GENOSS Co., Ltd. Registration: 3006223010 View Registration
PRAIS RELIABLE DENTAL SUPPLIES S.A Registration: 3006316962 View Registration
indigodental GmbH Registration: 3006694515 View Registration
medmix Deutschland GmbH Registration: 3007113445 View Registration
DENTSCARE LTDA Registration: 3007210751 View Registration
MANI MEDICAL GERMANY GmbH Registration: 3007584711 View Registration
US ORTHODONTIC PRODUCTS Registration: 3008005217 View Registration
Liaoning Upcera Co.,Ltd Registration: 3008254125 View Registration
INTERNATIONAL ORTHODONTIC SERVICES, PC Registration: 3008524225 View Registration
SAREMCO DENTAL AG Registration: 3008582054 View Registration
Xplora USA LLC Registration: 3008882689 View Registration
SAMTRADE SUPPLIES INC. Registration: 3008912871 View Registration
DMP Dental Industry S.A. Registration: 3008966075 View Registration
IVOCLAR VIVADENT, INC. Registration: 3009496224 View Registration
ELEVATE ORAL CARE, LLC Registration: 3009603151 View Registration
Keystone Industries - Gibbstown Registration: 3010002722 View Registration
Dharma Research/Medeco International Registration: 3010131268 View Registration
SIGNA MEDICAL, INC. Registration: 3010419931 View Registration
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3D DENTAL DESINGS AND DEVELOPMENT Registration: 3010864832 View Registration
EDELWEISSDR AG Registration: 3011148229 View Registration
PRISMATIK DENTALCRAFT, INC. Registration: 3011649314 View Registration
DYLAN LUCAS INTERNATIONAL INC Registration: 3011689956 View Registration
DENTSPLY IH BV Registration: 3011824442 View Registration
JERSEY DENTAL SUPPLIES Registration: 3012187973 View Registration
MHM GRUPO DIAMANTE, S.A. DE C.V. Registration: 3012354669 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
Kerr Corporation Registration: 3012477813 View Registration
SANICURE BV Registration: 3012494290 View Registration
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Solventum US LLC Registration: 3032163716 View Registration
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Kerr Corporation Registration: 3032378317 View Registration
Solventum Germany GmbH Registration: 3035693034 View Registration
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ZAPALIGN LLC Registration: 3043226252 View Registration
DENTSPLY DETREY GmbH Registration: 8010638 View Registration
SCHUETZ DENTAL GMBH Registration: 8010711 View Registration
VOCO GMBH Registration: 8010908 View Registration
Kerr Italia, S.r.l. Registration: 8020994 View Registration
SILMET LTD. Registration: 8030067 View Registration
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Solventum Germany GmbH Registration: 9611385 View Registration
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IVOCLAR VIVADENT AG Registration: 9612352 View Registration
COLTENE/WHALEDENT AG Registration: 9613375 View Registration
GC DENTAL PRODUCTS CORP. Registration: 9613953 View Registration
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IDENTA DENTAL MATERIAL GMBH Registration: 9680144 View Registration
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KETTENBACH GMBH & CO KG Registration: 9681356 View Registration

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