FDA 510(k) Premarket Notification K033295: BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN

Submission Details & Decision

Normalized public record details for 510(k) notification K033295.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K033295

Applicant / Sponsor

Novamin Technology, Inc.

Device Name

BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN

Product Code

LBH

Decision Date

2003-10-28

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

2003-10-14

Related Establishments / Registrations

B.J.M. LABORATORIES LTD Registration: 1000272892 View Registration
THE ATLANTA DENTAL SUPPLY COMPANY Registration: 1013257 View Registration
CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.) Registration: 1051594 View Registration
PREVENTIVE TECHNOLOGIES, INC. Registration: 1061053 View Registration
PULPDENT CORPORATION Registration: 1215305 View Registration
Tom's of Maine, Inc. Registration: 1218077 View Registration
CENTRIX, INC. Registration: 1281412 View Registration
Crosstex International Registration: 1319130 View Registration
GC AMERICA INC. Registration: 1410097 View Registration
DENTAL TECHNOLOGIES, INC. Registration: 1413475 View Registration
BISCO, INC. Registration: 1420052 View Registration
COSMEDENT, INC. Registration: 1450653 View Registration
Ultradent Products Inc. Registration: 1718912 View Registration
DENTONICS, INC. Registration: 1721647 View Registration
MEDENTAL INTL. Registration: 1723973 View Registration
CAO GROUP, INC. Registration: 1725006 View Registration
ADVANTAGE DENTAL PRODUCTS, INC. Registration: 1833025 View Registration
YOUNG DENTAL MANUFACTURING CO 1, LLC. Registration: 1941138 View Registration
DEN-MAT HOLDINGS, LLC Registration: 2018957 View Registration
SCIENTIFIC PHARMACEUTICALS, INC. Registration: 2022039 View Registration
DISCUS DENTAL, LLC Registration: 2031532 View Registration
PAC-DENT INC. Registration: 2086043 View Registration
INTER-MED, INC. Registration: 2133714 View Registration
PATTERSON DENTAL SUPPLY, INC. Registration: 2183301 View Registration
Kenvue Brands LLC Registration: 2214133 View Registration
Colgate-Palmolive Company Registration: 2218158 View Registration
CETYLITE INDUSTRIES, INC. Registration: 2242327 View Registration
DMG America LLC Registration: 2244812 View Registration
Ivoclar Vivadent Manufacturing, Inc Registration: 2244842 View Registration
DENTSPLY LLC Registration: 2424472 View Registration
TEMREX CORP. Registration: 2429849 View Registration
CARGUS INT'L, INC. Registration: 2437780 View Registration
PREMIER DENTAL PRODUCTS CO. Registration: 2511556 View Registration
MEDICAL PRODUCTS LABORATORIES, INC. Registration: 2513595 View Registration
DENTSPLY LLC Registration: 2515379 View Registration
Keystone Industries Registration: 2523320 View Registration
Patterson Dental Canada Inc. Registration: 3000219976 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
VERICOM CO., LTD. Registration: 3003449480 View Registration
TOKUYAMA DENTAL CORPORATION Kashima Factory Registration: 3003621174 View Registration
Menasha Packaging Company ,LLC Registration: 3003896222 View Registration
SDI LTD. Registration: 3004140838 View Registration
CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITED Registration: 3004475754 View Registration
Ivoclar Vivadent GmbH Registration: 3004966444 View Registration
NU RADIANCE, INC. Registration: 3004967419 View Registration
KULZER GMBH Registration: 3005665377 View Registration
Oral Biotech LLC Registration: 3005686375 View Registration
NUSMILE, LTD Registration: 3006444232 View Registration
Conamco SA de CV Medental Inc Registration: 3006805063 View Registration
medmix Deutschland GmbH Registration: 3007113445 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
3D DENTAL DESINGS AND DEVELOPMENT Registration: 3010864832 View Registration
NANOVA BIOMATERIALS INC Registration: 3011430871 View Registration
Pascal International, Inc. Registration: 3011632 View Registration
Summit Packaging Solutions LLC Registration: 3012117640 View Registration
Summit Packaging Solutions LLC Registration: 3012118920 View Registration
JERSEY DENTAL SUPPLIES Registration: 3012187973 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
SANICURE BV Registration: 3012494290 View Registration
VIARDEN LAB LLC Registration: 3012996495 View Registration
MEDICLUS CO., LTD Registration: 3013584861 View Registration
HEXA DENTAL Registration: 3014615644 View Registration
Menasha Packaging Company, LLC Registration: 3021035729 View Registration
CUMBERLAND BIOTHERAPEUTICS, LLC. Registration: 3025666291 View Registration
ZIRCON PLUS LIMITED Registration: 3026400121 View Registration
PHILIPS ORAL HEALTHCARE, LLC Registration: 3026630 View Registration
F & A LABORATORIO FARMACEUTICO LTDA Registration: 3027584973 View Registration
SILGAN UNICEP PACKAGING, LLC. Registration: 3028011 View Registration
Solventum US LLC Registration: 3031841433 View Registration
Solventum US LLC Registration: 3032163716 View Registration
OKETZ LOGISTICS LLC Registration: 3038718579 View Registration
SOLVENTUM US LLC Registration: 3042272797 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
VOCO GMBH Registration: 8010908 View Registration
KULZER GMBH Registration: 9610902 View Registration
Solventum Germany GmbH Registration: 9611385 View Registration
AMD Medicom Inc. Registration: 9611959 View Registration
GC CORP. Registration: 9612300 View Registration
IVOCLAR VIVADENT AG Registration: 9612352 View Registration
GC DENTAL PRODUCTS CORP. Registration: 9613953 View Registration
Voyant Beauty, Inc. Registration: 9615332 View Registration
IDENTA DENTAL MATERIAL GMBH Registration: 9680144 View Registration
CHX Technologies Inc. Registration: 9680945 View Registration
KETTENBACH GMBH & CO KG Registration: 9681356 View Registration

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