FDA 510(k) Premarket Notification K033020: IMPAK ACRYLIC REPAIR RESIN LIQUID

Submission Details & Decision

Normalized public record details for 510(k) notification K033020.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K033020

Applicant / Sponsor

Cmp Industries, LLC

Device Name

IMPAK ACRYLIC REPAIR RESIN LIQUID

Product Code

EBI

Decision Date

2003-12-19

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

2003-09-26

Related Establishments / Registrations

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. Registration: 1000118628 View Registration
POLIDENT d.o.o., Dental products industry Registration: 1000243214 View Registration
CANDULOR, AG Registration: 1000277456 View Registration
BREDENT GMBH & CO.KG Registration: 1000303432 View Registration
DREVE DENTAMID GMBH Registration: 1000486347 View Registration
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. Registration: 1000625496 View Registration
ZimVie US Corp LLC Registration: 1038806 View Registration
WHIP-MIX CORP. Registration: 1043617 View Registration
CONTECH MEDICAL, INC. Registration: 1221541 View Registration
BICON, LLC Registration: 1223843 View Registration
Great Lakes Dental Technologies, Ltd. Registration: 1316408 View Registration
GC AMERICA INC. Registration: 1410097 View Registration
RELIANCE DENTAL MFG., LLC Registration: 1415367 View Registration
YATES-MOTLOID Registration: 1416675 View Registration
LANG DENTAL MFG. CO., INC. Registration: 1417322 View Registration
FRICKE DENTAL MFG. CO. Registration: 1417846 View Registration
BISCO, INC. Registration: 1420052 View Registration
ASTRON DENTAL CORPORATION Registration: 1483306 View Registration
The Belport Company, Inc DBA Gingi-Pak Registration: 2014676 View Registration
ZEST ANCHORS, LLC Registration: 2023950 View Registration
Kerr Corporation Registration: 2024312 View Registration
Isomedix Operations Inc. Registration: 2032112 View Registration
THERMOPLASTIC COMFORT SYSTEMS, INC. Registration: 2032807 View Registration
J. MORITA USA, INC. Registration: 2081055 View Registration
PAC-DENT INC. Registration: 2086043 View Registration
REKO DENTAL, LLC Registration: 2087259 View Registration
INTER-MED, INC. Registration: 2133714 View Registration
PATTERSON DENTAL SUPPLY, INC. Registration: 2183301 View Registration
VYNACRON DENTAL RESINS, INC. Registration: 2242866 View Registration
Ivoclar Vivadent Manufacturing, Inc Registration: 2244842 View Registration
Keystone Industries Registration: 2280629 View Registration
PARKELL, INC. Registration: 2411797 View Registration
DENTSPLY LLC Registration: 2424472 View Registration
THE ARGEN CORPORATION Registration: 2433919 View Registration
PROTECH PROFESSIONAL PRODUCTS, INC. Registration: 2435952 View Registration
VALPLAST INTL. CORP. Registration: 2436918 View Registration
DENTSPLY LLC Registration: 2515379 View Registration
Keystone Industries Registration: 2523320 View Registration
SHOFU DENTAL CORP. Registration: 2916735 View Registration
Sterngold Dental LLC Registration: 2921595 View Registration
CO-ORAL-ITE DENTAL MFG. CO. Registration: 2950685 View Registration
JBC AND COMPANY Registration: 2954315 View Registration
DENTAL MANUFACTURING SPA Registration: 3001389926 View Registration
DELTAMED GMBH Registration: 3002789526 View Registration
GC CORPORATION-FUJI OYAMA FACTORY Registration: 3002807050 View Registration
WRIGHT HEALTH GROUP Registration: 3003103749 View Registration
BIOLOREN SRL Registration: 3003231822 View Registration
Ivoclar Vivadent Manufacturing GmbH Registration: 3003310824 View Registration
TOKUYAMA DENTAL CORPORATION Kashima Factory Registration: 3003621174 View Registration
DENTSPLY INDUSTRIA E COMERCIO LTDA Registration: 3003756493 View Registration
NEW STETIC Registration: 3003794907 View Registration
MYERSON LLC Registration: 3003928050 View Registration
INNOVATION MEDITECH GMBH Registration: 3004003391 View Registration
MERZ DENTAL GMBH Registration: 3004086252 View Registration
MICERIUM S.P.A. Registration: 3004130302 View Registration
SHEN FU ARTS LAB Registration: 3004578725 View Registration
PURPLE DENTAL TECH Registration: 3004905070 View Registration
DAVIS DENTAL LAB Registration: 3004935484 View Registration
Ivoclar Vivadent GmbH Registration: 3004966444 View Registration
SOMNOMED, LTD. Registration: 3005343849 View Registration
OLSON GLOBAL LABORATORY Registration: 3005344553 View Registration
UNION DENTAL S.A. Registration: 3005350578 View Registration
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SOMNOMED INC. Registration: 3005598536 View Registration
KULZER GMBH Registration: 3005665377 View Registration
ZIRKONZAHN SRL Registration: 3005904906 View Registration
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS Registration: 3006542438 View Registration
indigodental GmbH Registration: 3006694515 View Registration
SYNCA MARKETING Registration: 3006697692 View Registration
Yamahachi Dental Material (Changshu) Co., Ltd. Registration: 3006942327 View Registration
DIO Corporation Registration: 3007126709 View Registration
anax dent GmbH Registration: 3007791519 View Registration
Liaoning Upcera Co.,Ltd Registration: 3008254125 View Registration
Shandong Huge Dental Material Corporation Registration: 3008320092 View Registration
Dental Direkt GmbH Registration: 3008347275 View Registration
CLEMDE S.A. DE C.V. Registration: 3008494285 View Registration
ESSTECH, INC Registration: 3008569063 View Registration
HARVEST DENTAL PRODUCTS LLC Registration: 3008578884 View Registration
CFS DENTAL INC Registration: 3008590411 View Registration
BIO COMPOSANTS MEDICAUX (BCM) Registration: 3008757014 View Registration
Park Dental Research Corp Registration: 3008910197 View Registration
SAMTRADE SUPPLIES INC. Registration: 3008912871 View Registration
DENTCA, INC. Registration: 3009312537 View Registration
GARRECO, LLC Registration: 3009426332 View Registration
anax USA Registration: 3009432160 View Registration
SomnoMed Phillipines Inc. Registration: 3009440973 View Registration
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IVOCLAR VIVADENT, INC. Registration: 3009496224 View Registration
IMAGINE MILLING TECHNOLOGIES, LLC Registration: 3009727738 View Registration
Keystone Industries - Gibbstown Registration: 3010002722 View Registration
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Danville Materials Research Center Registration: 3010664129 View Registration
Kulzer SRL Registration: 3011203516 View Registration
Candulor Dental GmbH Registration: 3011511773 View Registration
PERFLEX LTD Registration: 3011532731 View Registration
PRISMATIK DENTALCRAFT, INC. Registration: 3011649314 View Registration
DENTSPLY IH BV Registration: 3011824442 View Registration
JERSEY DENTAL SUPPLIES Registration: 3012187973 View Registration
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MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
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SANICURE BV Registration: 3012494290 View Registration
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OTC DENTAL Registration: 3013425656 View Registration
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SPRINTRAY INC. Registration: 3014289665 View Registration
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AD SYSTEMS AND CONSULTING Registration: 3015532223 View Registration
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STRATASYS LTD Registration: 3016074824 View Registration
LUXCREO INC. Registration: 3016237718 View Registration
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OKETZ LOGISTICS LLC Registration: 3038718579 View Registration
ID KOREA CO., LTD. Registration: 3039359767 View Registration
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PAN-AM DENTAL, INC. Registration: 3040605150 View Registration
MAJOR PRODOTTI DENTARI S.P.A. Registration: 4565 View Registration
The Myerson Company Limited Registration: 8010019 View Registration
DENTSPLY DETREY GmbH Registration: 8010638 View Registration
SCHUETZ DENTAL GMBH Registration: 8010711 View Registration
VOCO GMBH Registration: 8010908 View Registration
PSP DENTAL CO., LTD. Registration: 8021851 View Registration
VERTEX-DENTAL B.V. Registration: 8030452 View Registration
DENTATUS AB Registration: 8030870 View Registration
POLYDENTIA S.A. Registration: 8031054 View Registration
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH Registration: 8044164 View Registration
KULZER GMBH Registration: 9610902 View Registration
GC CORP. Registration: 9612300 View Registration
IVOCLAR VIVADENT AG Registration: 9612352 View Registration
GC DENTAL PRODUCTS CORP. Registration: 9613953 View Registration
MANUFACTURERA DENTAL CONTINENTAL Registration: 9616065 View Registration
IDENTA DENTAL MATERIAL GMBH Registration: 9680144 View Registration
MAKEVALE, LTD. Registration: 9680348 View Registration
DETAX GMBH Registration: 9680954 View Registration
DEGUDENT GMBH Registration: 9681199 View Registration
S & C POLYMER GMBH Registration: 9681210 View Registration
KETTENBACH GMBH & CO KG Registration: 9681356 View Registration
DAVIS SCHOTTLANDER & DAVIS, LTD. Registration: 9681531 View Registration
STICK TECH LTD. Registration: 9710611 View Registration

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